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Terminated/Withdrawn
Sponsor ID
20120142

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

Sponsor ID
20120142
Clinicaltrials.gov ID
NCT02137343
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 3
Product
AMG 102
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
34
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression-free survival

Timeframe: 4 years

Overall Survival

Timeframe: 4 years

Secondary Outcome Measures

TTP

Timeframe: 4 years

ORR

Timeframe: 4 years

DCR

Timeframe: 4 years

TTR

Timeframe: 4 years

Incidence of subject adverse events, laboratory abnormalities and immunogenicity

Timeframe: 4 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Kitaadachi-gun, Saitama, Japan, 362-0806
Status
Recruiting
Location
Research Site
Chiba-shi, Chiba, Japan, 260-8717
Status
Recruiting
Location
Research Site
Kawasaki-shi, Kanagawa, Japan, 216-8511
Status
Recruiting
Location
Research Site
Osaka-shi, Osaka, Japan, 537-8511
Status
Recruiting
Location
Research Site
Utsunomiya-shi, Tochigi, Japan, 320-0834
Status
Recruiting
Location
Research Site
Fukuoka-shi, Fukuoka, Japan, 811-1395
Status
Recruiting
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Study Info
Age
20 - 100 Years
Condition
  • Gastrointestinal Cancer
    • Sex
    All
    Trial Dates
    Jul 2014 - Jun 2015
    Inclusion and Exclusion Criteria
    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.
    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.