Study Stopped
All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.
A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer
RILOMET-2
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
1 other identifier
interventional
34
2 countries
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 gastric-cancer
Started Jul 2014
Shorter than P25 for phase_3 gastric-cancer
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedApril 4, 2016
March 1, 2016
11 months
April 28, 2014
March 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-free survival
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
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 Outcomes (5)
TTP
4 years
ORR
4 years
DCR
4 years
TTR
4 years
Incidence of subject adverse events, laboratory abnormalities and immunogenicity
4 years
Study Arms (2)
Rilotumumab
EXPERIMENTALRilotumumab plus Cisplatin and Capecitabine (CX).
Placebo
PLACEBO COMPARATORRilotumumab-placebo plus Cisplatin and Capecitabine (CX).
Interventions
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.
A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (25)
Research Site
Nagoya, Aichi-ken, 464-8681, Japan
Research Site
Chiba, Chiba, 260-8717, Japan
Research Site
Kashiwa-shi, Chiba, 277-8577, Japan
Research Site
Matsuyama, Ehime, 791-0280, Japan
Research Site
Fukuoka, Fukuoka, 811-1395, Japan
Research Site
Sapporo, Hokkaido, 060-8648, Japan
Research Site
Akashi-shi, Hyōgo, 673-8558, Japan
Research Site
Kawasaki-shi, Kanagawa, 216-8511, Japan
Research Site
Osaka, Osaka, 537-8511, Japan
Research Site
Osaka, Osaka, 540-0006, Japan
Research Site
Osakasayama-shi, Osaka, 589-8511, Japan
Research Site
Suita-shi, Osaka, 565-0871, Japan
Research Site
Takatsuki-shi, Osaka, 569-8686, Japan
Research Site
Kitaadachi-gun, Saitama, 362-0806, Japan
Research Site
Suntou-gun, Shizuoka, 411-8777, Japan
Research Site
Utsunomiya, Tochigi, 320-0834, Japan
Research Site
Bunkyo-ku, Tokyo, 113-8677, Japan
Research Site
Goyang-si, Gyeonggi-do, 410-769, South Korea
Research Site
Hwasun, 519-763, South Korea
Research Site
Seoul, 110-744, South Korea
Research Site
Seoul, 120-752, South Korea
Research Site
Seoul, 135-710, South Korea
Research Site
Seoul, 136-705, South Korea
Research Site
Seoul, 137-701, South Korea
Research Site
Seoul, 138-736, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2014
First Posted
May 13, 2014
Study Start
July 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
April 4, 2016
Record last verified: 2016-03