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

March 4, 2016 updated by: Amgen

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 464-8681
        • Research Site
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8717
        • Research Site
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • Research Site
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 791-0280
        • Research Site
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 811-1395
        • Research Site
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-8648
        • Research Site
    • Hyogo
      • Akashi-shi, Hyogo, Japan, 673-8558
        • Research Site
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • Research Site
    • Osaka
      • Osaka-shi, Osaka, Japan, 540-0006
        • Research Site
      • Osaka-shi, Osaka, Japan, 537-8511
        • Research Site
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Research Site
      • Suita-shi, Osaka, Japan, 565-0871
        • Research Site
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Research Site
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Research Site
    • Shizuoka
      • Suntou-gun, Shizuoka, Japan, 411-8777
        • Research Site
    • Tochigi
      • Utsunomiya-shi, Tochigi, Japan, 320-0834
        • Research Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Research Site
  • Korea, Republic of
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Research Site
      • Hwasun, Korea, Republic of, 519-763
        • Research Site
      • Seoul, Korea, Republic of, 135-710
        • Research Site
      • Seoul, Korea, Republic of, 120-752
        • Research Site
      • Seoul, Korea, Republic of, 138-736
        • Research Site
      • Seoul, Korea, Republic of, 137-701
        • Research Site
      • Seoul, Korea, Republic of, 110-744
        • Research Site
      • Seoul, Korea, Republic of, 136-705
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rilotumumab
Rilotumumab plus Cisplatin and Capecitabine (CX).
Drug: Rilotumumab
Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter factor (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/SF/MET-driven activities in cells.
Other Names:
  • AMG102
Drug: Cisplatin
A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
Other Names:
  • Platinol
  • Platinal-AQ
Drug: Capecitabine
A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
Other Names:
  • Xeloda
Placebo Comparator: Placebo
Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Drug: Placebo
Placebo
Drug: Cisplatin
A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
Other Names:
  • Platinol
  • Platinal-AQ
Drug: Capecitabine
A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 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.
4 years
Overall Survival
Time Frame: 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.
4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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