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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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


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
- Significant cardiovascular disease or disorder

- History of abdominal fistula or gastrointestinal perforation 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

up to 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GO27827

NCT ID:

NCT01418222

Start Date:

September 2011

Completion Date:

June 2018

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Louisville, Kentucky  40207
McLean, Virginia  22101
Hackensack, New Jersey  07601
Denver, Colorado  
Baltimore, Maryland  21287
Charleston, South Carolina  
Tulsa, Oklahoma