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
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