Clareo Health | A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
With
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable to curative therapy
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Life expectancy greater than (\>) 3 months
Presence of tissue sample for IHC assay of MET receptor and HER2 status
Tumor (primary or metastatic lesion) defined as MET-positive by IHC
Measurable disease or non-measurable but evaluable disease, according to the RECIST v1.1; Participants 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 (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
You may not be 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 human growth factor (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
Pregnancy or lactation
Receipt of an investigational drug within 28 days prior to study start
Clinically significant gastrointestinal abnormalities, apart from gastric cancer, including uncontrolled inflammatory gastrointestinal diseases
Significant history of cardiac disease
Significant vascular disease
Serious active infection at the time of randomization, or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
Radiotherapy within 4 weeks before start of study treatment
Major surgery within 4 weeks before start of study treatment, without complete recovery
Any condition (psychological, geographical) that does not permit compliance with study and follow-up procedures
Peripheral neuropathy
Prior unanticipated severe reaction to fluoropyrimidine therapy
Known sensitivity or contraindication to any component of study treatment
