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

PHASE2CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

5-Fluorouracil

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.

DRUG

Bevacizumab

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.

DRUG

Folinic acid

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.

DRUG

MEGF0444A

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.

DRUG

Oxaliplatin

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.

DRUG

Placebo

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.

Trial Locations (40)

1070

Brussels

1200

Brussels

3000

Leuven

3011

Footscray

3084

Heidelberg

3168

Melbourne

4101

South Brisbane

5011

Woodville South

19104

Philadelphia

20007

Washington D.C.

27710

Durham

30045

Lawrenceville

30060

Marietta

32224

Jacksonville

34471

Ocala

34952

Port Saint Lucie

35205

Birmingham

39008

Santander

41013

Seville

46010

Valencia

46202

Indianapolis

55905

Rochester

60426

Harvey

80045

Aurora

85259

Scottsdale

89148

Las Vegas

90095

Los Angeles

91107

Pasadena

92835

Fullerton

93309

Bakersfield

93454

San Luis Obispo

90095-1772

Los Angeles

02114

Boston

02115

Boston

80-952

Gdansk

31-531

Krakow

61-878

Poznan

02-781

Warsaw

08035

Barcelona

08907

Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY

NCT01399684 - 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 | Biotech Hunter | Biotech Hunter