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

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

- Tumor (primary or metastatic lesion) defined as Met-positive by immunohistochemistry

- 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 another 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