A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Bevacizumab; Gedatolisib

Criteria

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 to the pelvis or abdomen in the metastatic or locally advanced setting.

• History of Gilbert's syndrome.

• Active brain metastases.

• Deep vein thrombosis in the preceding 2 months.

• History of interstitial lung disease.

• RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).