Gastric Cancer
Conditions
Keywords
Gastric Cancer, First Line Treatment Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer (GEJ), GEJ Cancer
Brief summary
This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal epithelial transition factor (MET)-positive gastric or gastroesophageal junction adenocarcinoma (GEJ).
Interventions
DRUGRilotumumab
Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter factor (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/SF/MET-driven activities in cells.
DRUGPlacebo
Placebo
DRUGCisplatin
A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
DRUGCapecitabine
A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Pathologically confirmed unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. * Tumor MET-positive by immunohistochemistry (IHC). * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. * Male or female subject greater than or equal to 20 years of age at the time of informed consent. Key
Exclusion criteria
* Human epidermal growth factor receptor 2 (HER2)-overexpressing locally advanced or metastatic gastric or GEJ adenocarcinoma. * Previous systemic therapy for locally advanced or metastatic gastric or GEJ or lower esophageal adenocarcinoma. * Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization. * Squamous cell histology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 4 years | To determine if the treatment of rilotumumab in combination with CX significantly improves progression-free survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression. |
| Overall Survival | 4 years | To determine if the treatment of rilotumumab in combination with CX significantly improves overall survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | 4 years | Disease Control Rate |
| TTP | 4 years | Time to Progression (TTP) |
| Incidence of subject adverse events, laboratory abnormalities and immunogenicity | 4 years | Adverse events and laboratory abnormalities are reported by Common Terminology Criteria for Adverse Events (CTCAE) (v3.0) |
| TTR | 4 years | Time to Response |
| ORR | 4 years | Objective Response Rate |
Countries
Japan, South Korea
Outcome results
None listed