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

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Disease Information

Descriptive Information
Brief Title † A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer
Official Title † 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
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
Study Phase Phase 3
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary Outcome Measure † Progression-free survival
Secondary Outcome Measure † TTP
Condition † Gastric Cancer
Intervention † DrugRilotumumab plus CX
Study Arms / Comparison Groups Rilotumumab Rilotumumab plus Cisplatin and Capecitabine (CX). Rilotumumab-placebo Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 34
Start Date † July 2014
Completion Date July 2015
Primary Completion Date June 2015
Eligibility 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.
Gender Both
Ages 20 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Japan
Administrative Information
NCT ID † NCT02137343
Organization ID 20120142
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Amgen
Collaborators ††
Investigators † Study Director: MD, Amgen
Information Provided By
Verification Date July 2015
First Received Date † April 28, 2014
Last Updated Date August 14, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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