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Irinotecan (CPT-11)

Alias: CPT-11; (+)-Irinotecan; Biotecan; Camptosar; Irinophore C; CPT 11;CPT11; Irinotecan; Irinotecan lactone; Irinotecanum
Cat No.:V1393 Purity: ≥98%
Irinotecan (also known as CPT-11; Camptosar; Irinophore C; CPT11; Irinotecan lactone; Irinotecanum), a semisynthetic analog of camptothecin and the prodrug of 7-ethyl-10-hydroxy-camptothecin (SN-38), is a topoisomerase I inhibitor approved for use as an anticancer drug.
Irinotecan (CPT-11)
Irinotecan (CPT-11) Chemical Structure CAS No.: 97682-44-5
Product category: Topoisomerase
This product is for research use only, not for human use. We do not sell to patients.
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Other Forms of Irinotecan (CPT-11):

  • Irinotecan hydrochloride
  • Irinotecan HCl Trihydrate
Official Supplier of:
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Purity & Quality Control Documentation

Purity: ≥98%

Product Description

Irinotecan (also known as CPT-11; Camptosar; Irinophore C; CPT11; Irinotecan lactone; Irinotecanum), a semisynthetic analog of camptothecin and the prodrug of 7-ethyl-10-hydroxy-camptothecin (SN-38), is a topoisomerase I inhibitor approved for use as an anticancer drug. In LoVo and HT-29 cells, it inhibits topoisomerase I with IC50 values of 15.8 μM and 5.17 μM, respectively.

Biological Activity I Assay Protocols (From Reference)
Targets
Topoisomerase I
ln Vitro

In vitro activity: Irinotecan is a topoisomerase I inhibitor. Irinotecan inhibits the growth of HT-29 and LoVo cells, causing comparable amounts of cleavable complexes in both cells, with IC50s of 5.17 ± 1.4 μM and 15.8 ± 5.1 μM, respectively[2]. With an inhibitory concentration (IC50) of 1.3 microM, irinotecan inhibits the growth of human umbilical vein endothelial cells (HUVEC)[3].

ln Vivo
Irinotecan (CPT-11, 5 mg/kg) significantly slows the growth of tumors when injected intratumorally into rats for five days straight over the course of two weeks. In mice, the same effect is achieved by continuously infusing osmotic minipump fluid intraperitoneally. But Irinotecan (10 mg/kg) has no effect on the tumor's ability to grow intraperitoneally[1]. In athymic female mice, irinotecan (CPT-11, 100-300 mg/kg, i.p.) appears to inhibit the growth of HT-29 xenograft tumors by day 21. At doses of 250 and 300 mg/kg, respectively, both the Irinotecan plus TSP-1 (10 mg/kg per day) and the Irinotecan (150 mg/kg) in combination with TSP-1 (20 mg/kg per day) groups are more effective than Irinotecan alone and inhibit tumor growth 84% and 89%, respectively[3].
Cell Assay
In 20 cm2 dishes, exponentially growing cells are seeded with the ideal number of cells for each cell line (20,000 for LoVo cells, 100,000 for HT-29 cells). They receive treatment with irinotecan or SN-38 at increasing concentrations for a single cell doubling period (24 hours for LoVo cells and 40 hours for HT-29 cells) after two days. Following a 0.15 M NaCl wash, the cells are cultured in normal medium for two more doubling times before being separated from the support using trypsin-EDTA and counted using a hemocytometer. Subsequently, the drug concentrations that cause a 50% inhibition of growth in cells treated with the drug are estimated as the IC50 values[2].
Animal Protocol
One cycle of therapy consists of injecting 0.1 cc of the suitable solution intraperitoneally (IV) with irinotecan at a dose of 5 mg/kg per day for 5 days on two consecutive weeks, separated by a 7-day rest period. Over the course of eight weeks, rats receive three cycles. By intratumoral injection, control animals are given 0.1 cc of sterile 0.9% sodium chloride solution according to the same protocol as group II animals[1].
ADME/Pharmacokinetics
Absorption, Distribution and Excretion
The maximum plasma concentration (Cmax) when a dose of 125 mg/m^2 is given to patients with solid tumours is 1660 ng/mL. The AUC (0-24) is 10,200 ng·h/mL. The Cmax when a dose of 340 mg/m^2 is given to patients with solid tumours is 3392 ng/mL. The AUC (0-24) is 20,604 ng·h/mL.
The cumulative biliary and urinary excretion of irinotecan and its metabolites (SN-38 and SN-38 glucuronide) over a period of 48 hours following administration of irinotecan in two patients ranged from approximately 25% (100 mg/m2) to 50% (300 mg/m2).
The volume of distribution of terminal elimination phase is 110 L/m^2 when a dose of 125 mg/m^2 is given to patients with solid tumours. The volume of distribution of terminal elimination phase is 234 L/m^2 when a dose of 340 mg/m^2 is given to patients with solid tumours.
13.3 L/h/m^2 [Dose of 125 mg/m^2, patients with solid tumours]
13.9 L/h/m^2 [Dose of 340 mg/m^2, patients with solid tumours]
Pharmacokinetic parameters for irinotecan and SN-38 were determined in 2 pediatric solid-tumor trials at dose levels of 50 mg/sq m (60-min infusion, n=48) and 125 mg/sq m (90-min infusion, n=6). Irinotecan clearance (mean + or - S.D.) was 17.3 + or - 6.7 L/h/sq m for the 50 mg/sq m dose and 16.2 + or - 4.6 L/h/sq m for the 125 mg/sq m dose, which is comparable to that in adults. Dose-normalized SN-38 AUC values were comparable between adults and children. Minimal accumulation of irinotecan and SN-38 was observed in children on daily dosing regimens (daily X 5 every 3 weeks or (daily X 5) X 2 weeks every 3 weeks).
The clinical pharmacokinetics of irinotecan (CPT11) can be described by a 2 or 3 compartment model, a mean terminal half-life of 12 hours, a volume of distribution at steady state of 168 L/sq m and a total body clearance of 15 L/sq m/hr. Irinotecan is 65% bound to plasma proteins. The areas under the plasma concentration-time curve (AUC) of both irinotecan and active metabolite SN38 increase proportionally to the administered dose, although interpatient variability is important. ... The mean 24 hr irinotecan urinary excretion represents 17-25% of the administered dose, whereas SN38 and its glucuronide recovery in urine is minimal (0.5 and 6%, respectively). Irinotecan and SN38 pharmacokinetics are not influenced by prior exposure to the parent drug. Irinotecan and SN38 AUCs correlate significantly with leuko-neutropenia and sometimes with the intensity of diarrhea. Increased bilirubin levels appear to influence irinotecan total body clearance.
Metabolism / Metabolites
Hepatic. The metabolic conversion of irinotecan to the active metabolite SN-38 is mediated by carboxylesterase enzymes and primarily occurs in the liver. SN-38 is subsequently conjugated predominantly by the enzyme UDP-glucuronosyl transferase 1A1 (UGT1A1) to form a glucuronide metabolite.
... SN38 levels achieved in humans are about 100-fold lower than corresponding irinotecan levels, but these concentrations are important since SN38 is 100- to 1,000-fold more cytotoxic than the parent compound. SN38 is 95% bound to plasma proteins. SN38 plasma decay follows closely that of the parent compound. Irinotecan is extensively metabolized in the liver. The bipiperidinocarbonyloxy group of irinotecan is first removed by a carboxyesterase to yield the corresponding carboxylic acid and SN38. This metabolite can be converted into SN38 glucuronide by UDP-glucuronyltransferase (1.1 isoform). A recently identified metabolite is the 7-ethyl-10-[4-N-(5-aminopentanoic acid)-1-piperidino]-carbonyloxy-camptothecin (APC), which is formed by the action of cytochrome P450 3A4. Numerous other unidentified metabolites are detected in bile and urine. ...
Irinotecan, a camptothecin analogue, is a prodrug which requires bioactivation to form the active metabolite SN-38. SN-38 acts as a DNA topoisomerase I poison. ... Irinotecan is subjected to be shunted between CYP3A4 mediated oxidative metabolism to form two inactive metabolites APC or NPC and tissue carboxylesterase mediated hydrolysis to form SN-38 which is eventually detoxified via glucuronidation by UGT1A1 to form SN-38G. The pharmacology of this compound is further complicated by the existence of genetic inter-individual differences in activation and deactivation enzymes of irinotecan (e.g., CYP3A4, CYP3A5, UGT1A1) and sharing competitive elimination pathways with many concomitant medications, such as anticonvulsants, St. John's Wort, and ketoconazole. Efflux of the parent compound and metabolites out of cells by several drug transporters (e.g., Pgp, BCRP, MRP1, MRP2) also occurs. This review highlights the latest findings in drug activation, transport mechanisms, glucuronidation, and CYP3A-mediated drug-drug interactions of irinotecan in order to unlock some of its complicated pharmacology and to provide ideas for relevant future studies into optimization of this promising agent.
Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN-38. SN-38 is formed from irinotecan by carboxylesterase-mediated cleavage of the carbamate bond between the camptothecin moiety and the dipiperidino side chain. SN-38 is approximately 1000 times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumor cell lines. In vitro cytotoxicity assays show that the potency of SN-38 relative to irinotecan varies from 2- to 2000-fold. However, the plasma area under the concentration versus time curve (AUC) values for SN-38 are 2% to 8% of irinotecan and SN-38 is 95% bound to plasma proteins compared to approximately 50% bound to plasma proteins for irinotecan. The precise contribution of SN-38 to the activity of Camptosar is thus unknown. Both irinotecan and SN-38 exist in an active lactone form and an inactive hydroxy acid anion form. A pH-dependent equilibrium exists between the two forms such that an acid pH promotes the formation of the lactone, while a more basic pH favors the hydroxy acid anion form.
The metabolic conversion of irinotecan to the active metabolite SN-38 is mediated by carboxylesterase enzymes and primarily occurs in the liver. SN-38 is subsequently conjugated predominantly by the enzyme UDP-glucuronosyl transferase 1A1 (UGT1A1) to form a glucuronide metabolite. UGT1A1 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity such as the UGT1A1*28 polymorphism. Approximately 10% of the North American population is homozygous for the UGT1A1*28 allele. In a prospective study, in which irinotecan was administered as a single-agent on a once-every-3-week schedule, patients who were homozygous for UGT1A1*28 had a higher exposure to SN-38 than patients with the wild-type UGT1A1 allele. SN-38 glucuronide had 1/50 to 1/100 the activity of SN-38 in cytotoxicity assays using two cell lines in vitro. The disposition of irinotecan has not been fully elucidated in humans. The urinary excretion of irinotecan is 11% to 20%; SN-38, <1%; and SN-38 glucuronide, 3%. The cumulative biliary and urinary excretion of irinotecan and its metabolites (SN-38 and SN-38 glucuronide) over a period of 48 hours following administration of irinotecan in two patients ranged from approximately 25% (100 mg/sq m) to 50% (300 mg/sq m).
Irinotecan has known human metabolites that include (2S,3S,4S,5R)-6-[[(19S)-10,19-diethyl-14,18-dioxo-7-(4-piperidin-1-ylpiperidine-1-carbonyl)oxy-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-19-yl]oxy]-3,4,5-trihydroxyoxane-2-carboxylic acid and 7-ethyl-10-[4-N-(5-aminopentanoic acid)-1-piperidino] carbonyloxycamptothecin.
Biological Half-Life
The half life of irinotecan is about 6 - 12 hours. The terminal elimination half-life of the active metabolite, SN-38 is 10 - 20 hours.
After intravenous infusion of irinotecan in humans, irinotecan plasma concentrations decline in a multiexponential manner, with a mean terminal elimination half-life of about 6 to 12 hours. The mean terminal elimination half-life of the active metabolite SN-38 is about 10 to 20 hours. The half-lives of the lactone (active) forms of irinotecan and SN-38 are similar to those of total irinotecan and SN-38, as the lactone and hydroxy acid forms are in equilibrium.
Toxicity/Toxicokinetics
Protein Binding
30%-68% protein bound, mainly to albumin.
Interactions
A total of 190 patients (49 smokers, 141 nonsmokers) treated with irinotecan (90-minute intravenous administration on a 3-week schedule) were evaluated for pharmacokinetics. Complete toxicity data were available in a subset of 134 patients receiving 350 mg/sq m or 600 mg flat-fixed dose irinotecan. In smokers, the dose-normalized area under the plasma concentration-time curve of irinotecan was significantly lower (median, 28.7 v 33.9 ng x hr/mL/mg; P = .001) compared with nonsmokers. In addition, smokers showed an almost 40% lower exposure to SN-38 (median, 0.54 v 0.87 ng x h/mL/mg; P < .001) and a higher relative extent of glucuronidation of SN-38 into SN-38G (median, 6.6 v 4.5; P = .006). Smokers experienced considerably less hematologic toxicity. In particular, the incidence of grade 3 to 4 neutropenia was 6% in smokers versus 38% in nonsmokers (odds ratio [OR], 0.10; 95% CI, 0.02 to 0.43; P < .001). There was no significant difference in incidence of delayed-onset diarrhea (6% v 15%; OR, 0.34; 95% CI, 0.07 to 1.57; P = .149). This study indicates that smoking significantly lowers both the exposure to irinotecan and treatment-induced neutropenia, indicating a potential risk of treatment failure. Although the underlying mechanism is not entirely clear, modulation of CYP3A and uridine diphosphate glucuronosyltransferase isoform 1A1 may be part of the explanation. The data suggest that additional investigation is warranted to determine whether smokers are at increased risk for treatment failure.
The coadministration of protease inhibitors with anticancer drugs in the management of human immunodeficiency virus-related malignancies can cause potential drug-drug interactions. The effect of lopinavir/ritonavir (LPV/RTV) on the pharmacokinetics of irinotecan (CPT11) has been investigated in seven patients with Kaposi's sarcoma. Coadministration of LPV/RTV reduces the clearance of CPT11 by 47% (11.3+/-3.5 vs 21.3+/-6.3 l/h/m(2), P=0.0008). This effect was associated with an 81% reduction (P=0.02) of the AUC (area under the curve) of the oxidized metabolite APC (7-ethyl-10-[4-N-(5-aminopentanoic-acid)-1-piperidino]-carbonyloxycamptothecin). The LPV/RTV treatment also inhibited the formation of SN38 glucuronide (SN38G), as shown by the 36% decrease in the SN38G/SN38 AUCs ratio (5.9+/-1.6 vs 9.2+/-2.6, P=0.002) consistent with UGT1A1 inhibition by LPV/RTV. This dual effect resulted in increased availability of CPT11 for SN38 conversion and reduced inactivation on SN38, leading to a 204% increase (P=0.0001) in SN38 AUC in the presence of LPV/RTV. The clinical consequences of these substantial pharmacokinetic changes should be investigated.
Irinotecan or CPT-11 [7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecine] is a derivative of camptothecine used in the treatment of advanced colorectal cancer. It requires activation to SN-38 (7-ethyl-10-hydroxycamptothecine) by carboxylesterase. Irinotecan and SN-38 are detoxified through two major metabolic pathways: the first one leads to oxidative degradation compounds, APC (7-ethyl-10-[4-N-(5-aminopentanoic acid)-1-piperidino)carbonyloxycamptothecine] and NPC [7-ethyl-10-(4-amino-1-piperidino)carbonyloxycamptothecine], and involves cytochrome P450 (3A4 isoform); the second one leads to SN-38 glucuronide (SN-38G) and involves UDP-glucuronosyltransferase (UGT). Using human hepatic microsomes, ... the interactions of 15 drugs of common use in colorectal cancer patients on these metabolic pathways /were studied/. Only nifedipine had a significant effect on SN-38 formation, decreasing carboxylesterase activity by 50% at 100 microM and 35% at 10 microM. Three drugs had a significant effect on SN-38G formation: clonazepam increased UGT activity by 50% at 100 uM and 30% at 10 microM, and nifedipine and vinorelbine inhibited the activity by 65 and 55% at 100 uM, respectively, with no effect at 10 microM. Five drugs exerted a significant inhibition on SN-38 formation at 100 microM: clonazepam (70%), methylprednisolone (50%), nifedipine (80%), omeprazole (85%), and vinorelbine (100%). Only omeprazole and vinorelbine still exerted a significant inhibition at 10 microM (30 and 90%, respectively), whereas only vinorelbine had a significant effect at 2 and 0.5 microM (70 and 40%, respectively). In conclusion, potential clinical interactions with the metabolism of irinotecan are likely to be important for vinorelbine, which strongly inhibits irinotecan catabolism by CYP3A4 at clinically relevant concentrations, but not for the other drugs, which exert an effect at concentrations not achievable in patients.
Coadministration of atazanavir sulfate, a CYP3A4 and UGT1A1 inhibitor has the potential to increase systemic exposure to SN-38, the active metabolite of irinotecan. Physicians should take this into consideration when co-administering these drugs.
For more Interactions (Complete) data for IRINOTECAN (12 total), please visit the HSDB record page.
References

[1]. Antitumoral effect of irinotecan (CPT-11) on an experimental model of malignant neuroectodermal tumor. J Neurooncol. 2002 Feb;56(3):219-26.

[2]. Determinants of the cytotoxicity of irinotecan in two human colorectal tumor cell lines. Cancer Chemother Pharmacol. 2002 Apr;49(4):329-35. Epub 2002 Jan 30.

[3]. Thrombospondin-1 plus irinotecan: a novel antiangiogenic-chemotherapeutic combination that inhibits the growth of advanced human colon tumor xenografts in mice. Cancer Chemother Pharmacol. 2004 Mar;53(3):261-6. Epub 2003 Dec 5.

[4]. A case study of an integrative genomic and experimental therapeutic approach for rare tumors: identification of vulnerabilities in a pediatric poorly differentiated carcinoma. Genome Med. 2016 Oct 31;8(1):116.

[5]. Chemotherapeutic agent CPT-11 eliminates peritoneal resident macrophages by inducing apoptosis. Apoptosis. 2016 Feb;21(2):130-42.

Additional Infomation
Therapeutic Uses
Irinotecan is used in combination with cisplatin for the initial treatment of extensive small cell lung cancer.
Irinotecan hydrochloride is used as a single agent for the treatment of metastatic carcinoma of the colon or rectum in patients whose disease has recurred or progressed following initial therapy with fluorouracil-based antineoplastic regimens. /Irinotecan hydrochloride/
Irinotecan is being investigated as an active agent in the treatment of metastatic or recurrent cervical cancer. Objective response rates of 13-21% have been reported with use of irinotecan as a single agent for advanced squamous cell carcinoma of the cervix. Although no responses to irinotecan were observed in one small uncontrolled phase II study of patients with platinum-resistant advanced squamous cell carcinoma of the cervix, responses to the drug have been reported in similar patients in another phase II study. The benefit of combination chemotherapy regimens vs single-agent therapy (e.g., cisplatin alone) has not been fully established, and further study is needed to determine the role of irinotecan in the treatment of advanced cervical cancer. /Use is not currently included in the labeling approved by the US FDA/
Irinotecan hydrochloride is used as a component of first-line therapy in combination with fluorouracil and leucovorin for the treatment of metastatic carcinoma of the colon or rectum. /Irinotecan hydrochloride/
The effectiveness of irinotecan in pediatric patients has not been established. Results from two open-label, single arm studies were evaluated. One hundred and seventy children with refractory solid tumors were enrolled in one phase 2 trial in which 50 mg/ sq m of irinotecan was infused for 5 consecutive days every 3 weeks. Grade 3-4 neutropenia was experienced by 54 (31.8%) patients. Neutropenia was complicated by fever in 15 (8.8%) patients. Grade 3-4 diarrhea was observed in 35 (20.6%) patients. This adverse event profile was comparable to that observed in adults. In the second phase 2 trial of 21 children with previously untreated rhabdomyosarcoma, 20 mg/sq m of irinotecan was infused for 5 consecutive days on weeks 0, 1, 3 and 4. This single agent therapy was followed by multimodal therapy. Accrual to the single agent irinotecan phase was halted due to the high rate (28.6%) of progressive disease and the early deaths (14%). The adverse event profile was different in this study from that observed in adults; the most significant grade 3 or 4 adverse events were dehydration experienced by 6 patients (28.6%) associated with severe hypokalemia in 5 patients (23.8%) and hyponatremia in 3 patients (14.3%); in addition Grade 3-4 infection was reported in 5 patients (23.8%) (across all courses of therapy and irrespective of causal relationship).
Drug Warnings
Camptosar injection should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Camptosar can induce both early and late forms of diarrhea that appear to be mediated by different mechanisms. Both forms of diarrhea may be severe. Early diarrhea (occurring during or shortly after infusion of Camptosar) may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Early diarrhea and other cholinergic symptoms may be prevented or ameliorated by atropine. Late diarrhea (generally occurring more than 24 hours after administration of Camptosar) can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Late diarrhea should be treated promptly with loperamide. Patients with diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated or antibiotic therapy if they develop ileus, fever, or severe neutropenia. Administration of Camptosar should be interrupted and subsequent doses reduced if severe diarrhea occurs. Severe myelosuppression may occur.
Close monitoring is advised in patients older than 65 years of age because of increased risk of treatment-related toxicity, such as late diarrhea, during irinotecan therapy. Patients receiving irinotecan/fluorouracil/leucovorin therapy should be monitored closely (e.g., weekly assessment), particularly during the first cycle of treatment, since most of the treatment-related toxicities leading to early death occurred within the first 3-4 weeks. Changes in serum electrolytes and/or acid-base balance, including hyponatremia or hypernatremia, hypokalemia, and/or metabolic acidosis, may be an early indication of treatment-related toxicity; patients with abnormalities in serum sodium, potassium, and/or bicarbonate concentrations, with or without concomitant elevations in serum BUN or creatinine concentrations, should be evaluated carefully for dehydration and receive aggressive medical management, including fluid and electrolyte replacement.
Deaths due to sepsis following severe neutropenia have been reported in patients treated with Camptosar.
In addition to GI and hematologic toxicity, other severe adverse effects have occurred in patients receiving irinotecan. Hypersensitivity reactions, including severe anaphylactic or anaphylactoid reactions, have been reported. Renal impairment and acute renal failure have occurred rarely, usually in patients who became volume-depleted from severe vomiting and/or diarrhea. Cardiovascular and thromboembolic events also have been reported.
For more Drug Warnings (Complete) data for IRINOTECAN (19 total), please visit the HSDB record page.
Pharmacodynamics
Irinotecan is an antineoplastic enzyme inhibitor primarily used in the treatment of colorectal cancer. Irinotecan is a semisynthetic derivative of camptothecin. Camptothecins interact specifically with topoisomerase I, an enzyme in the cell nucleus that regulates DNA topology and facilitates nuclear processes such as DNA replication, recombination, and repair. During these processes, topoisomerase I relieves torsional strain in DNA by inducing reversible single-strand breaks, allowing single DNA strands to pass through the break. The 3'-DNA terminus of the broken DNA strands bind covalently with the topoisomerase enzyme to form a catalytic intermediate called a cleavable complex. After the DNA is sufficiently relaxed and the strand passage reaction is complete, DNA topoisomerase reattaches the broken DNA strands to form the chemically unaltered topoisomers that allow transcription to proceed. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I-DNA complex and prevent religation of these single-strand breaks. Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either Irinotecan or SN-38. Mammalian cells cannot efficiently repair these double-strand breaks. The precise contribution of SN-38 to the activity of irinotecan in humans is not known. Irinotecan is cell cycle phase-specific (S-phase).
These protocols are for reference only. InvivoChem does not independently validate these methods.
Physicochemical Properties
Molecular Formula
C33H38N4O6
Molecular Weight
586.68
Exact Mass
586.279
Elemental Analysis
C, 67.56; H, 6.53; N, 9.55; O, 16.36
CAS #
97682-44-5
Related CAS #
100286-90-6 (HCl); 136572-09-3 (HCl trihydrate); 143490-53-3 (Lactone Impurity) ; 97682-44-5; 1329502-92-2 (Carboxylate Sodium Salt)
PubChem CID
60838
Appearance
White to yellow solid powder
Density
1.4±0.1 g/cm3
Boiling Point
873.4±65.0 °C at 760 mmHg
Melting Point
222-223 °C
222-223 °C
222 - 223 °C
Flash Point
482.0±34.3 °C
Vapour Pressure
0.0±0.3 mmHg at 25°C
Index of Refraction
1.689
LogP
4.35
Hydrogen Bond Donor Count
1
Hydrogen Bond Acceptor Count
8
Rotatable Bond Count
5
Heavy Atom Count
43
Complexity
1200
Defined Atom Stereocenter Count
1
SMILES
C(C1C2C=C(C=CC=2N=C2C3=CC4[C@@](C(OCC=4C(=O)N3CC=12)=O)(O)CC)OC(N1CCC(N2CCCCC2)CC1)=O)C
InChi Key
UWKQSNNFCGGAFS-XIFFEERXSA-N
InChi Code
InChI=1S/C33H38N4O6/c1-3-22-23-16-21(43-32(40)36-14-10-20(11-15-36)35-12-6-5-7-13-35)8-9-27(23)34-29-24(22)18-37-28(29)17-26-25(30(37)38)19-42-31(39)33(26,41)4-2/h8-9,16-17,20,41H,3-7,10-15,18-19H2,1-2H3/t33-/m0/s1
Chemical Name
[(19S)-10,19-diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-7-yl] 4-piperidin-1-ylpiperidine-1-carboxylate
Synonyms
CPT-11; (+)-Irinotecan; Biotecan; Camptosar; Irinophore C; CPT 11;CPT11; Irinotecan; Irinotecan lactone; Irinotecanum
HS Tariff Code
2934.99.9001
Storage

Powder      -20°C    3 years

                     4°C     2 years

In solvent   -80°C    6 months

                  -20°C    1 month

Note: This product requires protection from light (avoid light exposure) during transportation and storage.
Shipping Condition
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
Solubility Data
Solubility (In Vitro)
DMSO: 7~25 mg/mL (11.9~42.6 mM)
Water: <1 mg/mL
Ethanol: <1 mg/mL
Solubility (In Vivo)
Solubility in Formulation 1: ≥ 2.08 mg/mL (3.55 mM) (saturation unknown) in 10% DMSO + 40% PEG300 + 5% Tween80 + 45% Saline (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 20.8 mg/mL clear DMSO stock solution to 400 μL PEG300 and mix evenly; then add 50 μL Tween-80 to the above solution and mix evenly; then add 450 μL normal saline to adjust the volume to 1 mL.
Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH₂ O to obtain a clear solution.

Solubility in Formulation 2: ≥ 2.08 mg/mL (3.55 mM) (saturation unknown) in 10% DMSO + 90% (20% SBE-β-CD in Saline) (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 20.8 mg/mL clear DMSO stock solution to 900 μL of 20% SBE-β-CD physiological saline solution and mix evenly.
Preparation of 20% SBE-β-CD in Saline (4°C,1 week): Dissolve 2 g SBE-β-CD in 10 mL saline to obtain a clear solution.

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Solubility in Formulation 3: ≥ 2.08 mg/mL (3.55 mM) (saturation unknown) in 10% DMSO + 90% Corn Oil (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 20.8 mg/mL clear DMSO stock solution to 900 μL of corn oil and mix evenly.


Solubility in Formulation 4: 30% Propylene glycol , 5% Tween 80 , 65% D5W: 30 mg/mL

 (Please use freshly prepared in vivo formulations for optimal results.)
Preparing Stock Solutions 1 mg 5 mg 10 mg
1 mM 1.7045 mL 8.5225 mL 17.0451 mL
5 mM 0.3409 mL 1.7045 mL 3.4090 mL
10 mM 0.1705 mL 0.8523 mL 1.7045 mL

*Note: Please select an appropriate solvent for the preparation of stock solution based on your experiment needs. For most products, DMSO can be used for preparing stock solutions (e.g. 5 mM, 10 mM, or 20 mM concentration); some products with high aqueous solubility may be dissolved in water directly. Solubility information is available at the above Solubility Data section. Once the stock solution is prepared, aliquot it to routine usage volumes and store at -20°C or -80°C. Avoid repeated freeze and thaw cycles.

Calculator

Molarity Calculator allows you to calculate the mass, volume, and/or concentration required for a solution, as detailed below:

  • Calculate the Mass of a compound required to prepare a solution of known volume and concentration
  • Calculate the Volume of solution required to dissolve a compound of known mass to a desired concentration
  • Calculate the Concentration of a solution resulting from a known mass of compound in a specific volume
An example of molarity calculation using the molarity calculator is shown below:
What is the mass of compound required to make a 10 mM stock solution in 5 ml of DMSO given that the molecular weight of the compound is 350.26 g/mol?
  • Enter 350.26 in the Molecular Weight (MW) box
  • Enter 10 in the Concentration box and choose the correct unit (mM)
  • Enter 5 in the Volume box and choose the correct unit (mL)
  • Click the “Calculate” button
  • The answer of 17.513 mg appears in the Mass box. In a similar way, you may calculate the volume and concentration.

Dilution Calculator allows you to calculate how to dilute a stock solution of known concentrations. For example, you may Enter C1, C2 & V2 to calculate V1, as detailed below:

What volume of a given 10 mM stock solution is required to make 25 ml of a 25 μM solution?
Using the equation C1V1 = C2V2, where C1=10 mM, C2=25 μM, V2=25 ml and V1 is the unknown:
  • Enter 10 into the Concentration (Start) box and choose the correct unit (mM)
  • Enter 25 into the Concentration (End) box and select the correct unit (mM)
  • Enter 25 into the Volume (End) box and choose the correct unit (mL)
  • Click the “Calculate” button
  • The answer of 62.5 μL (0.1 ml) appears in the Volume (Start) box
g/mol

Molecular Weight Calculator allows you to calculate the molar mass and elemental composition of a compound, as detailed below:

Note: Chemical formula is case sensitive: C12H18N3O4  c12h18n3o4
Instructions to calculate molar mass (molecular weight) of a chemical compound:
  • To calculate molar mass of a chemical compound, please enter the chemical/molecular formula and click the “Calculate’ button.
Definitions of molecular mass, molecular weight, molar mass and molar weight:
  • Molecular mass (or molecular weight) is the mass of one molecule of a substance and is expressed in the unified atomic mass units (u). (1 u is equal to 1/12 the mass of one atom of carbon-12)
  • Molar mass (molar weight) is the mass of one mole of a substance and is expressed in g/mol.
/

Reconstitution Calculator allows you to calculate the volume of solvent required to reconstitute your vial.

  • Enter the mass of the reagent and the desired reconstitution concentration as well as the correct units
  • Click the “Calculate” button
  • The answer appears in the Volume (to add to vial) box
In vivo Formulation Calculator (Clear solution)
Step 1: Enter information below (Recommended: An additional animal to make allowance for loss during the experiment)
Step 2: Enter in vivo formulation (This is only a calculator, not the exact formulation for a specific product. Please contact us first if there is no in vivo formulation in the solubility section.)
+
+
+

Calculation results

Working concentration mg/mL;

Method for preparing DMSO stock solution mg drug pre-dissolved in μL DMSO (stock solution concentration mg/mL). Please contact us first if the concentration exceeds the DMSO solubility of the batch of drug.

Method for preparing in vivo formulation:Take μL DMSO stock solution, next add μL PEG300, mix and clarify, next addμL Tween 80, mix and clarify, next add μL ddH2O,mix and clarify.

(1) Please be sure that the solution is clear before the addition of next solvent. Dissolution methods like vortex, ultrasound or warming and heat may be used to aid dissolving.
             (2) Be sure to add the solvent(s) in order.

Clinical Trial Information
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
CTID: NCT05945823
Phase: Phase 2    Status: Recruiting
Date: 2024-12-02
Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
CTID: NCT06625320
Phase: Phase 3    Status: Recruiting
Date: 2024-12-02
A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)
CTID: NCT05342636
Phase: Phase 1/Phase 2    Status: Active, not recruiting
Date: 2024-12-02
Photoradiation with Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
CTID: NCT06381154
Phase: Phase 2    Status: Not yet recruiting
Date: 2024-12-02
A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
CTID: NCT06459180
Phase: Phase 3    Status: Recruiting
Date: 2024-12-02
View More

Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
CTID: NCT06172296
Phase: Phase 3    Status: Recruiting
Date: 2024-12-02


Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)
CTID: NCT05239741
Phase: Phase 3    Status: Recruiting
Date: 2024-12-02
A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)
CTID: NCT06356311
Phase: Phase 3    Status: Recruiting
Date: 2024-12-02
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
CTID: NCT05286814
Phase: Phase 2    Status: Recruiting
Date: 2024-11-26
Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
CTID: NCT03009058
Phase: Phase 1/Phase 2    Status: Terminated
Date: 2024-11-25
A Study of ASP3082 in Adults With Advanced Solid Tumors
CTID: NCT05382559
Phase: Phase 1    Status: Recruiting
Date: 2024-11-25
Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver
CTID: NCT03366155
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-11-25
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer
CTID: NCT06538207
Phase: Phase 1    Status: Active, not recruiting
Date: 2024-11-25
CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer
CTID: NCT03699319
Phase: Phase 1/Phase 2    Status: Completed
Date: 2024-11-22
Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651/KEYNOTE-651)
CTID: NCT03374254
Phase: Phase 1    Status: Completed
Date: 2024-11-21
Nordic Pancreatic Cancer Trial (NorPACT) - 1
CTID: NCT02919787
Phase: Phase 2/Phase 3    Status: Active, not recruiting
Date: 2024-11-20
A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
CTID: NCT05319730
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-11-20
N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
CTID: NCT06528496
Phase: Phase 2    Status: Recruiting
Date: 2024-11-20
Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS
CTID: NCT06692491
Phase: Phase 2    Status: Not yet recruiting
Date: 2024-11-18
Chemotherapy in Patients With Relapsed Small Cell Lung Cancer in Combination With Allopurinol and MycoPhenolate (CLAMP Trial)
CTID: NCT05049863
Phase: Phase 1    Status: Active, not recruiting
Date: 2024-11-18
A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
CTID: NCT06586515
Phase: Phase 1    Status: Recruiting
Date: 2024-11-18
An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer
CTID: NCT06532344
Phase: Phase 1    Status: Active, not recruiting
Date: 2024-11-14
M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)
CTID: NCT06509906
Phase: Phase 1    Status: Recruiting
Date: 2024-11-12
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
CTID: NCT04607421
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-11-12
The Sagittarius Trial
CTID: NCT06490536
Phase: Phase 3    Status: Recruiting
Date: 2024-11-12
A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
CTID: NCT06607185
Phase: Phase 1    Status: Recruiting
Date: 2024-11-12
Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
CTID: NCT01864109
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-11-12
A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer
CTID: NCT05365581
Phase: Phase 1    Status: Recruiting
Date: 2024-11-08
9-ING-41 in Pediatric Patients with Refractory Malignancies.
CTID: NCT04239092
Phase: Phase 1    Status: Recruiting
Date: 2024-11-08
9-ING-41 in Patients with Advanced Cancers
CTID: NCT03678883
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-11-07
CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer
CTID: NCT03206151
Phase: Phase 3    Status: Completed
Date: 2024-11-07
NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
CTID: NCT06450041
Phase: Phase 2    Status: Recruiting
Date: 2024-11-06
Study of CtDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas
CTID: NCT04920032
Phase: Phase 1    Status: Recruiting
Date: 2024-11-06
Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
CTID: NCT05863195
Phase: Phase 3    Status: Recruiting
Date: 2024-11-05
Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab
CTID: NCT06107413
Phase: Phase 2    Status: Recruiting
Date: 2024-11-05
CtDNA-Directed Post-Hepatectomy Chemotherapy for Patients with Resectable Colorectal Liver Metastases
CTID: NCT05062317
Phase: Phase 2    Status: Recruiting
Date: 2024-11-04
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
CTID: NCT06541262
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-11-01
RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors
CTID: NCT04525014
Phase: Phase 1    Status: Terminated
Date: 2024-10-31
New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study
CTID: NCT04481204
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-10-28
CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized CRC
CTID: NCT06652412
Phase: Phase 2    Status: Not yet recruiting
Date: 2024-10-28
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
CTID: NCT05677490
Phase: Phase 3    Status: Recruiting
Date: 2024-10-26
A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
CTID: NCT03430843
Phase: Phase 3    Status: Completed
Date: 2024-10-26
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation
CTID: NCT05610163
Phase: Phase 2    Status: Recruiting
Date: 2024-10-26
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
CTID: NCT04322318
Phase: Phase 2    Status: Recruiting
Date: 2024-10-26
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
CTID: NCT05379595
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-10-24
Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma
CTID: NCT03323034
Phase: Phase 1    Status: Completed
Date: 2024-10-22
Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)
CTID: NCT04385277
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-10-22
AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma
CTID: NCT05669339
Phase: Phase 1    Status: Recruiting
Date: 2024-10-17
A Study of Ifinatamab Deruxtecan in Subjects With Advanced or Metastatic ESCC (IDeate-Esophageal01)
CTID: NCT06644781
Phase: Phase 3    Status: Not yet recruiting
Date: 2024-10-16
Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
CTID: NCT04199026
PhaseEarly Phase 1    Status: Not yet recruiting
Date: 2024-10-15
A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer
CTID: NCT02096354
Phase: Phase 2    Status: Completed
Date: 2024-10-15
Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery
CTID: NCT03533582
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-10-15
CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
CTID: NCT05440786
Phase: Phase 2    Status: Recruiting
Date: 2024-10-15
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.
CTID: NCT05022654
Phase: Phase 2    Status: Recruiting
Date: 2024-10-15
DS-3201b and Irinotecan for Patients With Recurrent Small Cell Lung Cancer
CTID: NCT03879798
Phase: Phase 1/Phase 2    Status: Terminated
Date: 2024-10-10
PhII ICb With/Without Erbitux in MBC Pts
CTID: NCT00248287
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-10-08
Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma
CTID: NCT06620302
Phase: Phase 1/Phase 2    Status: Not yet recruiting
Date: 2024-10-08
Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis
CTID: NCT01847495
Phase: N/A    Status: Withdrawn
Date: 2024-10-04
A Phase Ib Trial of Eribulin in Combination with Irinotecan and Temozolamide in Children with Relapsed or Refractory Solid Tumors
CTID: NCT06006273
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-10-04
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
CTID: NCT06219941
Phase: Phase 2    Status: Recruiting
Date: 2024-10-04
A Study of the Drugs Prexasertib, Irinotecan, and Temozolomide in People With Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma
CTID: NCT04095221
Phase: Phase 1/Phase 2    Status: Active, not recruiting
Date: 2024-10-03
AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
CTID: NCT06346392
Phase: Phase 3    Status: Recruiting
Date: 2024-10-02
The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer
CTID: NCT05628038
Phase: Phase 2    Status: Recruiting
Date: 2024-10-01
IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting
CTID: NCT02967289
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-10-01
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
CTID: NCT04117945
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-09-27
Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer
CTID: NCT04725994
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-09-27
A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
CTID: NCT05999994
Phase: Phase 2    Status: Recruiting
Date: 2024-09-27
VITAS: Atezolizumab in Combination with Chemotherapy for Pediatric Relapsed/refractory Solid Tumors
CTID: NCT04796012
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-09-24
TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study
CTID: NCT04109924
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-09-24
Zimberelimab and Quemliclustat in Combination with Chemotherapy for the Treatment of Patients with Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
CTID: NCT05688215
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-09-23
Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients
CTID: NCT03829462
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-09-20
Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer
CTID: NCT02138617
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-09-19
AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients
CTID: NCT04513951
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-09-19
Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies
CTID: NCT04361708
Phase: Phase 1    Status: Recruiting
Date: 2024-09-19
Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.
CTID: NCT05838768
Phase: Phase 1    Status: Recruiting
Date: 2024-09-19
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
CTID: NCT03709680
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-09-19
A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)
CTID: NCT04008030
Phase: Phase 3    Status: Recruiting
Date: 2024-09-19
mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma
CTID: NCT04251715
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-09-19
Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma
CTID: NCT05546853
Phase: Phase 1    Status: Recruiting
Date: 2024-09-19
A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.
CTID: NCT01916447
Phase: Phase 1    Status: Completed
Date: 2024-09-05
A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer
CTID: NCT05678257
Phase: Phase 2    Status: Terminated
Date: 2024-09-03
Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.
CTID: NCT04753879
Phase: Phase 2    Status: Recruiting
Date: 2024-08-23
Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers
CTID: NCT04205968
Phase: Phase 2    Status: Recruiting
Date: 2024-08-16
A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)
CTID: NCT06401330
Phase: Phase 3    Status: Not yet recruiting
Date: 2024-08-12
Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study
CTID: NCT06547203
Phase: Phase 2    Status: Recruiting
Date: 2024-08-09
Nivolumab in Combination With Chemotherapy Pre-Surgery in Treating Patients With Borderline Resectable Pancreatic Cancer
CTID: NCT03970252
PhaseEarly Phase 1    Status: Completed
Date: 2024-08-09
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
CTID: NCT04657068
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-08-09
Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy
CTID: NCT01871766
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-08-09
Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
CTID: NCT04697628
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-08-09
FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer
CTID: NCT04141995
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-08-07
131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma
CTID: NCT04743661
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-08-06
Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma
CTID: NCT01505608
Phase: Phase 1/Phase 2    Status: Terminated
Date: 2024-08-06
Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)
CTID: NCT05153239
Phase: Phase 3    Status: Recruiting
Date: 2024-08-02
A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
CTID: NCT03872947
Phase: Phase 1    Status: Recruiting
Date: 2024-08-02
Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer
CTID: NCT05722327
Phase: Phase 1    Status: Recruiting
Date: 2024-08-02
A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma
CTID: NCT06238843
Phase: Phase 3    Status: Enrolling by invitation
Date: 2024-07-26
Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29
CTID: NCT05253846
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-07-25
Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.
CTID: NCT06514313
Phase: Phase 2    Status: Recruiting
Date: 2024-07-23
Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
CTID: NCT05330429
Phase: Phase 2    Status: Terminated
Date: 2024-07-23
A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma
CTID: NCT06512428
Phase: Phase 2    Status: Recruiting
Date: 2024-07-22
Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer
CTID: NCT06509126
Phase: Phase 3    Status: Recruiting
Date: 2024-07-19
SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies
CTID: NCT05039944
Phase: Phase 2    Status: Terminated
Date: 2024-07-18
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
CTID: NCT04329494
Phase: Phase 1    Status: Recruiting
Date: 2024-07-18
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
CTID: NCT06304974
Phase: Phase 3    Status: Recruiting
Date: 2024-07-18
Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab
CTID: NCT00891930
Phase: Phase 2    Status: Completed
Date: 2024-07-17
A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer
CTID: NCT05546411
Phase: Phase 2    Status: Terminated
Date: 2024-07-16
Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC
CTID: NCT06501664
Phase: Phase 3    Status: Not yet recruiting
Date: 2024-07-15
Lurbinectedin or in Combination With Irinotecan Versus Topotecan in Patients With Relapsed SCLC
CTID: NCT06496048
Phase: Phase 3    Status: Not yet recruiting
Date: 2024-07-11
De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer
CTID: NCT02842580
Phase: Phase 2    Status: Terminated
Date: 2024-07-10
Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors
CTID: NCT05620862
Phase: Phase 1    Status: Active, not recruiting
Date: 2024-07-09
MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer
CTID: NCT05462236
Phase: Phase 2    Status: Recruiting
Date: 2024-07-09
A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas
CTID: NCT01837862
Phase: Phase 1/Phase 2    Status: Completed
Date: 2024-07-05
Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC
CTID: NCT05229003
Phase: Phase 2    Status: Recruiting
Date: 2024-07-03
Study of Chemoimmunotherapy for High-Risk Neuroblastoma
CTID: NCT03189706
PhaseEarly Phase 1    Status: Active, not recruiting
Date: 2024-07-03
LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.
CTID: NCT06351020
Phase: Phase 3    Status: Recruiting
Date: 2024-07-01
A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma
CTID: NCT03693807
Phase: Phase 2    Status: Completed
Date: 2024-07-01
FOLFIRINOX + NIS793 in Pancreatic Cancer
CTID: NCT05417386
Phase: Phase 1    Status: Terminated
Date: 2024-06-25
Ramucirumab Plus Irinotecan for Previously Treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
CTID: NCT03141034
Phase: Phase 2    Status: Completed
Date: 2024-06-25
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
CTID: NCT04238819
Phase: Phase 1/Phase 2    Status: Active, not recruiting
Date: 2024-06-21
XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)
CTID: NCT06055179
Phase: N/A    Status: Recruiting
Date: 2024-06-20
iTTo for Treatment Naive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
CTID: NCT04808791
Phase: Phase 2    Status: Completed
Date: 2024-06-14
Study of Sequential High-dose Chemotherapy in Children With High Risk Medulloblastoma
CTID: NCT02025881
Phase: Phase 1/Phase 2    Status: Terminated
Date: 2024-05-24
FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma
CTID: NCT04625907
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-05-23
RegoNivo vs Standard of Care Chemotherapy in AGOC
CTID: NCT04879368
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-05-16
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
CTID: NCT04221035
Phase: Phase 3    Status: Recruiting
Date: 2024-05-16
Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer
CTID: NCT06417476
Phase: Phase 2    Status: Recruiting
Date: 2024-05-16
Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer
CTID: NCT03641313
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-05-16
Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children
CTID: NCT02308527
Phase: Phase 2    Status: Active, not recruiting
Date: 2024-05-14
Paediatric Hepatic International Tumour Trial
CTID: NCT03017326
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-05-13
Adjuvant Trial in Patients With Resected PDAC Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature
CTID: NCT05314998
Phase: Phase 3    Status: Not yet recruiting
Date: 2024-05-13
Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients
CTID: NCT01941316
Phase: Phase 1/Phase 2    Status: Completed
Date: 2024-05-09
EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer
CTID: NCT06011772
PhaseEarly Phase 1    Status: Recruiting
Date: 2024-05-03
A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors
CTID: NCT06394713
Phase: Phase 1/Phase 2    Status: Not yet recruiting
Date: 2024-05-01
Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors
CTID: NCT02611024
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-04-30
Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC
CTID: NCT04587128
Phase: Phase 2    Status: Recruiting
Date: 2024-04-30
Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas
CTID: NCT02192359
Phase: Phase 1    Status: Active, not recruiting
Date: 2024-04-29
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
Biological Data
  • Genome Med . 2016 Oct 31;8(1):116.
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