NCT01937715

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	PF-05212384	PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly
DRUG	FOLFIRI regimen	The RP2D/MTD dose of FOLFIRI regimen every 2 weeks
BIOLOGICAL	Bevacizumab	5 mg/m\^2 every 2 weeks or 7.5 mg/m\^2 every 3 weeks
DRUG	FOLFIRI	Full dose FOLFIRI regimen every 2 weeks

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-09-09
• Last updated: 2016-08-18
• Results posted: 2016-08-18

Locations

39 sites across 3 countries: United States, Canada, Spain