First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma (RILOMET-1)

Amgen

Status and phase: Terminated; Phase 3

Conditions: Gastric Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01697072

20070622

2011-004923-11 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 609 patients

Sex: All

Ages: 18 to 99 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)
• 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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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609 participants in 2 patient groups, including a placebo group

Rilotumumab

Experimental group

Description:

Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)

Treatment:

Drug: Epirubicin

Drug: Cisplatin

Drug: Rilotumumab

Drug: Capecitabine

Placebo

Placebo Comparator group

Description:

Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)

Treatment:

Drug: Epirubicin

Drug: Cisplatin

Other: Placebo

Drug: Capecitabine