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

Phase 3

Terminated

• Conditions: Gastric Cancer
• Interventions: Drug: Placebo; Drug: Rilotumumab; Drug: Cisplatin; Drug: Capecitabine

• Registration Number: NCT02137343
• Lead Sponsor: Amgen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Study Start: 2014-07
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Disposition First Submitted: 2015-10-28
• Disposition First Submitted QC: 2015-10-28
• Disposition First Posted: 2015-11-24
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Rilotumumab	Cisplatin	Rilotumumab plus Cisplatin and Capecitabine (CX).
Rilotumumab	Capecitabine	Rilotumumab plus Cisplatin and Capecitabine (CX).
Placebo	Cisplatin	Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Placebo	Capecitabine	Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Rilotumumab	Rilotumumab	Rilotumumab plus Cisplatin and Capecitabine (CX).

Primary Outcome Measures

Name	Time	Method
Progression-free survival	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	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 Outcome Measures

Name	Time	Method
TTP	4 years	Time to Progression (TTP)
ORR	4 years	Objective Response Rate
DCR	4 years	Disease Control Rate
TTR	4 years	Time to Response
Incidence of subject adverse events, laboratory abnormalities and immunogenicity	4 years	Adverse events and laboratory abnormalities are reported by Common Terminology Criteria for Adverse Events (CTCAE) (v3.0)

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of