A Phase III Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic HER2-Negative And Met-Positive Gastroesophageal Cancer (MetGastric)
Study Status
Open to Enrollment
Study Description
The purpose of this clinical trial is to determine the effectiveness of the experimental drug onartuzumab (also called MetMab) in combination with mFOLFOX6 chemotherapy in treating HER2-negative gastric cancer.
Receptors are specific sites on the surface of cancer cells that tell the cell to do something, such as grow, divide, spread, or other actions. The Met receptor has been shown to be important in the growth and spread of cancer cells. Onartuzumab is monoclonal antibody (a type of protein commonly made by the immune system) that attaches to the Met receptor and prevents Met from activating tumor cells. Therefore onartuzumab combined with chemotherapy may help slow the spread of gastric cancer.
Study participants will be randomly assigned to one of two study arms:
- Arm A: Onartuzumab via infusion + mFOLFOX6 chemotherapy
- Arm B: Placebo (an inactive substance) via infusion + mFOLFOX6 chemotherapy
Participants will receive the chemotherapy with either onartuzumab or placebo for 12 cycles. Each cycle is 14 days. For participants whose tumor has decreased in size or remained stable after completing these 12 cycles, they may continue to receive onartuzumab or placebo without the mFOLFOX6 chemotherapy until they are no longer responding to treatment.
Disease Status and/or Stage
Metastatic Gastric Cancer
Sponsor
Genentech
Key Eligibility
- Age 18 and older
- Gastric cancer
- Inoperable, metastatic disease
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Alice Mercado, RN
- (212) 746-5430
- [email protected]
- GI Oncology Medical Practice
- 646-962-6200
Protocol ID
YO28322
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Erica Bersin
Tel: (646) 962-8232
[email protected]
