An Open-Label, Multi-Center, Randomized Phase 1b/2 Study Of PF-05212384 Plus 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria: - Advanced colorectal carcinoma. - Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting. - Tumor tissue available at time of screening for molecular profiling. - Adequate performance status. - Adequate glucose control, bone marrow, kidney, liver, and heart function. Exclusion Criteria: - Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation. - Prior irinotecan treatment. - Prior radiation therapy to greater than 20% of pelvis. - History of Gilbert's syndrome. - Active brain metastases. - Deep vein thrombosis in the preceding 2 months. - History of interstitial lung disease.

Last updated:

8/4/2014

NCT ID:

NCT01937715

IRB Number:

13-007682