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Terminated/Withdrawn
Sponsor ID
20070622

First-Line Treatment for locally advanced or metastatic mesenchymal epithelial transition factor (MET) - positive gastric, lower esophageal, or gastroesophageal junction (GEJ) adenocarcinomaRILOMET-1

Sponsor ID
20070622
Clinicaltrials.gov ID
NCT01697072
EUCTIS ID
N/A
EudraCT ID
2011-004923-11
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Study Details

This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin & capecitabine (ECX) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma

Additional Study Details

Phase
Phase 3
Product
rilotumumab
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
609
Additional Study Details

Protocol Summary

Primary Outcome Measures

Overall Survival

Timeframe: 3 years

Secondary Outcome Measures

PFS

Timeframe: 3 years

TTP

Timeframe: 3 years

ORR

Timeframe: 3 years

DCR

Timeframe: 3 years

TTR

Timeframe: 3 years

Safety

Timeframe: 3 years

Immunogenicity

Timeframe: 3 years

Study Documents

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

Locations

Location
Status
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Location
Research Site
Greensboro, NC, United States, 27403
Status
Completed
Location
Research Site
Kurralta Park, SA, Australia, 5037
Status
Recruiting
Location
Research Site
Pueblo, CO, United States, 81008
Status
Recruiting
Location
Research Site
Winston Salem, NC, United States, 27103
Status
Recruiting
Location
Research Site
Laval, QC, Canada, H7M 3L9
Status
Recruiting
Location
Research Site
Bedford, TX, United States, 76022
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Gastrointestinal Cancer
    • Sex
    All
    Trial Dates
    Oct 2012 - Nov 2014
    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) •Evaluable (measurable or non-measurable) disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
    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 adenocarcinoma •Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization •Previous treatment with anthracyclines must not exceed total cumulative dose of epirubicin of 400 mg/m2 •Squamous cell histology •Left ventricular ejection fraction (LVEF) < 50%