drugset / Trial / NCT01925274
A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.
Timeline
- Start
- 2013-11-15
- Primary completion
- 2016-04-06
- Completion
- 2016-04-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cetuximab | Monoclonal antibody | 400 mg/m2 | Intravenous |
| Subject | Gedatolisib | Small molecule | 110 mg | Intravenous |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |