A Study Evaluating the Efficacy and Safety of MEGF0444A Dosed to Progression in Combination With Bevacizumab and mFOLFOX-6 in Participants With Previously Untreated Metastatic Colorectal Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT01399684
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-Fluorouracil — DRUG
    Participants will receive 5-fluorouracil 400 milligrams per squared meter (mg/m\^2) intravenous (IV) bolus and then 2400 mg/m\^2 as a continuous IV infusion over 46-48 hours on Day 1 of every cycle until disease progression, unacceptable toxicity or at the maximum of 52 cycles, whichever occurs first.
  • Bevacizumab — DRUG
    Participants will be administered bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 14 days until disease progression or unacceptable toxicity, for a maximum of 52 cycles, whichever occurs first.
  • Folinic acid — DRUG
    Participants will receive folinic acid 400 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression, unacceptable toxicity or at the maximum of 52 cycles, whichever occurs first.
  • MEGF0444A — DRUG
    Participants will be administered MEGF0444A at a fixed dose of 400 milligrams (mg) IV on Day 1 of Cycle 1, followed by subsequent doses of 400 mg every 14 days until disease progression or unacceptable toxicity, for a maximum of 52 cycles, whichever occurs first.
  • Oxaliplatin — DRUG
    Participants will receive oxaliplatin 85 mg/m\^2 IV infusion over 90 minutes on Day 1 of every cycle for a maximum of 8 cycles.
  • Placebo — DRUG
    Participants will be administered MEGF0444A matching placebo every 14 days until disease progression, unacceptable toxicity or at the maximum of 52 cycles, whichever occurs first.

Study Details

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to estimate the efficacy of MEGF0444A treatment to disease progression, combined with oxaliplatin + folinic acid + 5-Fluorouracil (mFOLFOX-6) + bevacizumab therapy in participants with metastatic colorectal cancer (CRC).

Key Dates

First listed
Jul 22, 2011
Start date
Nov 30, 2011
Status verified
Aug 2016
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

Enrollment
127 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MEGF0444A + mFOLFOX-6 + Bevacizumab
    Participants will receive MEGF0444A + mFOLFOX-6 (oxaliplatin, folinic acid, and 5-fluorouracil) regimen + bevacizumab. Participants will receive oxaliplatin for up to 8 cycles (Cycle = 14 days) and 5-fluorouracil, folinic acid, bevacizumab and MEGF0444A will be administered until disease progression or unacceptable toxicity for a maximum of up to 52 cycles.
  • Placebo Comparator: Placebo + mFOLFOX-6 + Bevacizumab
    Participants will receive MEGF0444A matching placebo + mFOLFOX-6 regimen + bevacizumab. Participants will receive oxaliplatin for up to 8 cycles and 5-fluorouracil, folinic acid, bevacizumab and placebo will be administered until disease progression or unacceptable toxicity for a maximum of up to 52 cycles.

Primary Outcome Measure

Progression-Free Survival Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 as Determined by the Investigator [ Time Frame: Screening up to disease progression or death due to any cause, whichever occurs first (assessed every 8-9 weeks after Cycle 1 Day 1 up to approximately 27 months overall) ]

Locations (23)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama35205-
-ScottsdaleArizona85259-
-BakersfieldCalifornia93309-
-FullertonCalifornia92835-
-Los AngelesCalifornia90095-1772-
-Los AngelesCalifornia90095-
-PasadenaCalifornia91107-
-San Luis ObispoCalifornia93454-
-AuroraColorado80045-
-Washington D.C.District of Columbia20007-
-JacksonvilleFlorida32224-
-OcalaFlorida34471-
-Port Saint LucieFlorida34952-
-LawrencevilleGeorgia30045-
-MariettaGeorgia30060-
-HarveyIllinois60426-
-IndianapolisIndiana46202-
-BostonMassachusetts02114-
-BostonMassachusetts02115-
-RochesterMinnesota55905-
-Las VegasNevada89148-
-DurhamNorth Carolina27710-
-PhiladelphiaPennsylvania19104-

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