A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

123

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Gastric Cancer
Interventions
DRUG

Placebo

Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

DRUG

Onartuzumab (MetMAb)

Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

DRUG

Folinic acid

Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

DRUG

Levofolinic acid

If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

DRUG

5-Fluorouracil

5-Fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

Trial Locations (36)

100

Taipei

333

Taoyuan

2139

Sydney

3084

Heidelberg

4029

Herston

5011

Woodville South

6009

Nedlands

10065

New York

10330

Bangkok

10400

Bangkok

10700

Bangkok

12206

Albany

22031

Fairfax

23226

Richmond

33705

St. Petersburg

33908

Fort Myers

37203

Nashville

45219

Cincinnati

60637

Chicago

60714

Niles

75702

Tyler

76022

Bedford

77060

Garland

77380

The Woodlands

78731

Austin

80218

Denver

98684

Vancouver

119228

Singapore

169610

Singapore

06520

New Haven

VIC 3165

East Bentleigh

05505

Seoul

06351

Seoul

135-720

Seoul

00704

Tainan City

00112

Taipei

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY