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

NCT01937715 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-08-18

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States
  • Canada
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01937715 on ClinicalTrials.gov