A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) 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
- 34
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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).
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
- •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.
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.
Arms & Interventions
Rilotumumab
Rilotumumab plus Cisplatin and Capecitabine (CX).
Intervention: Rilotumumab
Rilotumumab
Rilotumumab plus Cisplatin and Capecitabine (CX).
Intervention: Cisplatin
Rilotumumab
Rilotumumab plus Cisplatin and Capecitabine (CX).
Intervention: Capecitabine
Placebo
Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Intervention: Placebo
Placebo
Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Intervention: Cisplatin
Placebo
Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Intervention: Capecitabine
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 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
Time Frame: 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 Outcomes
- TTP(4 years)
- ORR(4 years)
- DCR(4 years)
- TTR(4 years)
- Incidence of subject adverse events, laboratory abnormalities and immunogenicity(4 years)