A Phase 3 interventional study of Rilotumumab and Placebo in Gastric Cancer, sponsored by Amgen. Terminated at 25 sites in 2 countries. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-04-04.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
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).
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 34 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Rilotumumab plus Cisplatin and Capecitabine (CX).
Drug: Rilotumumab · Drug: Cisplatin · Drug: Capecitabine
Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Drug: Placebo · Drug: Cisplatin · Drug: Capecitabine
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.
Also known as: AMG102
Placebo
A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
Also known as: Platinol, Platinal-AQ
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.
Also known as: Xeloda
Progression-free survival
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.
Time frame: 4 years
Overall Survival
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.
Time frame: 4 years
TTP
Time to Progression (TTP)
Time frame: 4 years
ORR
Objective Response Rate
Time frame: 4 years
DCR
Disease Control Rate
Time frame: 4 years
TTR
Time to Response
Time frame: 4 years
Incidence of subject adverse events, laboratory abnormalities and immunogenicity
Adverse events and laboratory abnormalities are reported by Common Terminology Criteria for Adverse Events (CTCAE) (v3.0)
Time frame: 4 years
This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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