Gastric Cancer
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
DRUGOxaliplatin
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
DRUGFolinic acid
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
DRUGLevofolinic acid
If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
DRUG5-Fluorouracil
5-Fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Sponsors
Genentech, Inc.
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) in all patients | Up to 18 months |
| Progression-free survival (PFS) in patients with Met-positive tumors | Up to 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety: incidence of adverse events | 18 months |
| Overall survival (OS) | 18 months |
| Overall response rate (ORR) | 18 months |
| Duration of response (DOR) | 18 months |
Countries
Australia, Singapore, South Korea, Taiwan, Thailand, United States
Outcome results
None listed