drugset / Trial / NCT01523431
Individual Dosage Selection of Irinotecan (CPT-11) Based on UGT1A1 Genotype in Metastatic Colorectal Cancer Patients
Phase 2/3
Completed
583 enrolled
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to investigate the influence of dose selection of CPT-11 on toxicity, response and pharmacokinetics according to UGT1A1 genotype in colorectal cancer patients.
Timeline
- Start
- 2012-03-08
- Primary completion
- 2015-11-23
- Completion
- 2016-04-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 90 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |