A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
18 Years
N/A
Both
Gastric Cancer
Trial Information
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
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)
- Evaluable (measurable or non-measurable) disease by Response Evaluation Criteria In
Solid Tumors (RECIST) 1.1 criteria
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 adenocarcinoma
- Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant
chemotherapy or chemoradiotherapy to randomization
- Previous treatment with anthracyclines must not exceed total cumulative dose of
epirubicin of 400 mg/m2
- Squamous cell histology
- Left ventricular ejection fraction (LVEF) < 50%
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
To determine if the treatment of rilotumumab in combination with ECX significantly improves overall survival in subjects with unresectable locally advanced or metastatic MET positive gastric or GEJ cancer
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20070622
NCT ID:
NCT01697072
Start Date:
October 2012
Completion Date:
December 2016
Related Keywords:
- Gastric Cancer
- Gastric Cancer
- First Line Treatment Gastroesophageal Junction (GEJ)
- Gastroesophageal Junction Cancer (GEJ)
- GEJ Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Stomach Neoplasms
Name | Location |
|---|---|
| Research Site | Mesa, Arizona |
| Research Site | Boulder, Colorado |
| Research Site | Arlington Heights, Illinois |
| Research Site | Baltimore, Maryland |
| Research Site | Alexandria, Minnesota |
| Research Site | Las Vegas, Nevada |
| Research Site | Albany, New York |
| Research Site | Asheville, North Carolina |
| Research Site | Allentown, Pennsylvania |
| Research Site | Chattanooga, Tennessee |
| Research Site | Abilene, Texas |
