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
Overview
- Phase
- Phase 3
- Intervention
- Rilotumumab
- Conditions
- Gastric Cancer
- Sponsor
- Amgen
- Enrollment
- 609
- Locations
- 1
- Primary Endpoint
- Overall Survival
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin & capecitabine (ECX) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
Investigators
Eligibility Criteria
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%
Exclusion Criteria
- Not provided
Arms & Interventions
Rilotumumab
Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Intervention: Rilotumumab
Rilotumumab
Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Intervention: Epirubicin
Rilotumumab
Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Intervention: Cisplatin
Rilotumumab
Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Intervention: Capecitabine
Placebo
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Intervention: Placebo
Placebo
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Intervention: Epirubicin
Placebo
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Intervention: Cisplatin
Placebo
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Intervention: Capecitabine
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 3 years
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
Secondary Outcomes
- Immunogenicity(3 years)
- TTR(3 years)
- Safety(3 years)
- DCR(3 years)
- PFS(3 years)
- TTP(3 years)
- ORR(3 years)