drugset / Trial / NCT01937715
A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
RandomizedSingle-groupOpen-labelTreatment
Summary
This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI. The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.
Timeline
- Start
- 2014-02
- Primary completion
- 2015-08
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 5 mg/m2 | — |
| Comparator | Bevacizumab | Monoclonal antibody | 7.5 mg/m2 | — |
| Subject | Gedatolisib | Small molecule | — | — |