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A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic HER2-Negative Gastroesophageal Cancer

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Disease Information

Descriptive Information
Brief Title † A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic HER2-Negative Gastroesophageal Cancer
Official Title † A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Onartuzumab (MetMAb) In Combination With 5-Fluorouracil, Folinic Acid, And Oxaliplatin (mFOLFOX6) In Patients With Metastatic HER2-Negative Gastroesophageal Cancer
Brief Summary This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinue treatment.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary Outcome Measure † Progression-free survival (PFS) in all patients
Secondary Outcome Measure † Safety: incidence of adverse events
Condition † Gastric Cancer
Intervention † DrugPlacebo
Study Arms / Comparison Groups Onartuzumab Arm Placebo Arm
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 123
Start Date † July 2012
Completion Date October 2014
Primary Completion Date October 2014
Eligibility Criteria † Inclusion Criteria: - Adult patients, 18 years of age and older - Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable for curative therapy - ECOG performance status 0 or 1 - Life expectancy >3 months - Presence of tissue sample for immunohistochemistry assay of Met receptor and HER2 status (if unknown) - Radiographic evidence of disease; measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1); Patients with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial. - For women who are not postmenopausal or surgically sterile; agreement to use an adequate method of contraception (e.g., hormonal implant) during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin - For men: agreement to use a barrier method of contraception during the treatment period and for 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin - Adequate laboratory values Exclusion Criteria: - HER2-positive tumor (primary tumor or metastasis) - Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization) - Prior treatment with investigational drugs that target the HGF or Met pathway - History of other malignancy within the previous 5 years, except for appropriately treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, and localized prostate cancer - Receipt of an investigational drug within 28 days prior to study start - Clinically significant gastrointestinal abnormalities, except from gastric cancer (e.g., Crohn's disease) - Significant history of cardiac disease - Significant vascular disease - Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Australia
Administrative Information
NCT ID † NCT01590719
Organization ID YO28252
Secondary IDs †† 2012-000858-57
Responsible Party Sponsor
Study Sponsor † Hoffmann-La Roche
Collaborators †† Genentech, Inc.
Investigators † Study Director: Clinical Trials, Hoffmann-La Roche
Information Provided By
Verification Date October 2015
First Received Date † May 2, 2012
Last Updated Date October 1, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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