A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer (RILOMET-2)

Amgen

Status and phase: Terminated; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Capecitabine; Drug: Rilotumumab; Drug: Placebo; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02137343

20120142

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

Rilotumumab

Experimental group

Description:

Rilotumumab plus Cisplatin and Capecitabine (CX).

Treatment:

Drug: Cisplatin

Drug: Rilotumumab

Drug: Capecitabine

Placebo

Placebo Comparator group

Description:

Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).

Treatment:

Drug: Cisplatin

Drug: Placebo

Drug: Capecitabine