A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Capecitabine; Cisplatin; Rilotumumab

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.