Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Irinotecan, irinotecan hydrochloride
Irinotecan+ Carboplatin · 11 trials · 16 indications
PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.
OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.
OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.
time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (≥) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment.
To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Tumor response according to RECIST.
Tumor response according to RECIST.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| Temozolomide + Irinotecan | EXPERIMENTAL | - |
| Arm 1 | ACTIVE_COMPARATOR | irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle (Arm 1, ICb) |
| Arm 2 | EXPERIMENTAL | irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2 Week 1 and then 250 mg/m2 weekly thereafter, (Arm 2, ICb+Erbitux) |
| irinitecan/cisplatin | EXPERIMENTAL | experimental arm consists of patients who receive irinotecan/cisplatin |
| Name | Type | Description |
|---|---|---|
| 5 fluorouracil | DRUG | 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days |
| irinotecan | DRUG | 180mg/m2 iv day 1 every 14 days |
| levo- leucovorin | DRUG | 200mg/m2 iv; day 1 every 14 days |
| sunitinib | DRUG | 37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period |
| placebo | DRUG | 37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period |
| Etoposide + cisplatin | DRUG | etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle |
| Irinotecan + cisplatin | DRUG | irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle |
| Irinotecan + 5 FU + folinic acid | DRUG | irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks |
| Folinic Acid + 5 FU | DRUG | folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks |
| FOLFIRI regimen | DRUG | - |
| fluorouracil | DRUG | - |
| irinotecan hydrochloride | DRUG | - |
| leucovorin calcium | DRUG | - |
| Temozolomide | DRUG | Temozolomide 100-125 mg/m\^2 daily on days 1-5 in repeated 3 week cycles |
| Irinotecan + Carboplatin | DRUG | irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle |
| irinotecan + Carboplatin + erbitux | DRUG | irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2 |
| Docetaxel | DRUG | - |
| Irinotecan plus capecitabine | DRUG | Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for |
Inclusion Criteria: * Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease. * Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated. * Adequate organ function defined by blood test. Exclusion ...
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Irinotecan is an oncology drug studied in several solid tumor types, including breast neoplasms, hepatocellular carcinoma, non-small-cell lung carcinoma, colorectal cancer, and glioma. It is used in combination regimens such as irinotecan plus capecitabine, irinotecan plus carboplatin, irinotecan plus cisplatin, and FOLFIRI, which combines irinotecan with 5-FU and folinic acid.
Irinotecan targets TOP1, also known as topoisomerase I. It is a small-molecule inhibitor of this enzyme. By inhibiting topoisomerase I, irinotecan interferes with DNA replication in tumor cells. This mechanism underlies its development as a chemotherapy agent across the cancer types studied.
Pfizer, Inc., ticker PFE, is the developer associated with irinotecan in this program. Pfizer is a large pharmaceutical company, and irinotecan is one of its oncology assets. The drug is also known as irinotecan hydrochloride and is studied in multiple combination regimens.
Irinotecan is in Phase 2 development for the indications studied here. It is an investigational small-molecule TOP1 inhibitor, and the clinical program includes Phase 2 and Phase 3 trials. The Phase 2 designation reflects the stage of the studies listed for this asset.
Irinotecan has been studied in trials including NCT00635323, a Phase 2 trial of irinotecan plus capecitabine as first-line treatment in Asian subjects with hepatocellular carcinoma, and NCT00457691, a Phase 3 study of FOLFIRI chemotherapy with or without sunitinib in metastatic colorectal cancer. Other trials include NCT00404495 in children with brain tumors and NCT00248287 in metastatic breast cancer.
Irinotecan is also known as irinotecan hydrochloride. It is studied in several combination regimens, including irinotecan plus carboplatin, irinotecan plus cisplatin, irinotecan plus capecitabine, and irinotecan plus 5-FU plus folinic acid, the regimen commonly called FOLFIRI. These names refer to the same drug given with different chemotherapy partners.