Clinical Trials/NCT01418222

NCT01418222

Completed

Phase 2

Randomized, Double-Blind, Phase II Study of FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment for Patients With Metastatic Colorectal Cancer

Genentech, Inc.23 sites in 1 country194 target enrollmentSeptember 14, 2011

ConditionsColorectal Cancer

Interventions5-FU FOLFOX regimen bevacizumab [Avastin]leucovorin onartuzumab [MetMAb]Placebo

Drugs5-FU FOLFOX regimen Placebo bevacizumab [Avastin]leucovorin onartuzumab [MetMAb]

Overview

Phase: Phase 2
Intervention: 5-FU
Conditions: Colorectal Cancer
Sponsor: Genentech, Inc.
Enrollment: 194
Locations: 23
Primary Endpoint: Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.

Registry

clinicaltrials.gov

Start Date

September 14, 2011

End Date

March 18, 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•Measurable disease by RECIST criteria
•Adequate organ system function, as defined by protocol

Exclusion Criteria

•Prior systemic or radiation therapy for metastatic colorectal cancer
•Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease
•Previously untreated brain metastases
•History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency
•Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
•History of hematemesis or hemoptysis \</= 1 months prior to study enrollment
•Significant cardiovascular disease or disorder
•History of abdominal fistula or gastrointestinal perforation \</= 6 months prior to Day 1
•Positive for hepatitis B, hepatitis C or HIV infection
•Other active cancers or history of treatment for invasive cancer within the last 5 years, except for non-melanoma skin cancer

Arms & Interventions

A

Intervention: 5-FU

A

Intervention: FOLFOX regimen

A

Intervention: bevacizumab [Avastin]

A

Intervention: leucovorin

A

Intervention: onartuzumab [MetMAb]

B

Intervention: 5-FU

B

Intervention: FOLFOX regimen

B

Intervention: Placebo

B

Intervention: bevacizumab [Avastin]

B

Intervention: leucovorin

Outcomes

Primary Outcomes

Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria

Time Frame: up to 4 years

Secondary Outcomes

Response rate (complete response + partial response)(up to 4 years)
Overall survival(up to 4 years)
Safety: Incidence of adverse events(up to 4 years)
Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death(up to 4 years)