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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastric Cancer

In brief

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.

Key facts

Study ID

NCT01590719

Run by

Hoffmann-La Roche

People needed

123

Starts

2012-07-01

Expected to finish

2014-10-01

Last updated by the study team

2016-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients, 18 years of age and older
• Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable for curative therapy
• Eastern Cooperative Oncology Group (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

You may not qualify if…

• 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 hepatocyte growth factor (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

Where it is running

• Study site — Denver, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Fort Myers, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Niles, Illinois, United States
• Study site — Albany, New York, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Bedford, Texas, United States
• Study site — Garland, Texas, United States
• Study site — The Woodlands, Texas, United States
• Study site — Tyler, Texas, United States
• Study site — Fairfax, Virginia, United States
• Study site — Richmond, Virginia, United States
• Study site — Vancouver, Washington, United States
• Study site — Sydney, New South Wales, Australia
• Study site — Herston, Queensland, Australia
• Study site — Woodville South, South Australia, Australia
• Study site — East Bentleigh, Victoria, Australia
• Study site — Heidelberg, Victoria, Australia
• Study site — Nedlands, Western Australia, Australia
• Study site — Singapore, Singapore

Full record on ClinicalTrials.gov

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