Status:
COMPLETED
A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
Lead Sponsor:
Eli Lilly and Company
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel...
Detailed Description
The aim of this study is to determine if paclitaxel given together with ramucirumab (IMC-1211B) as second line therapy will prolong overall survival (OS) compared to paclitaxel alone. Approximately 6...
Eligibility Criteria
Inclusion
- Signed informed consent
- histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
- Metastatic disease or locally advanced, unresectable disease
- Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline)
- Organs are functioning well (liver, kidney, blood)
- Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1
Exclusion
- First line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline
- Previous systemic therapy with other anti-angiogenic drugs
- Uncontrolled high blood pressure
- Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month
- Evidence of central nervous system (CNS) metastasis at baseline
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
665 Patients enrolled
Trial Details
Trial ID
NCT01170663
Start Date
December 1 2010
End Date
February 1 2017
Last Update
September 18 2019
Active Locations (167)
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1
ImClone Investigational Site
Burbank, California, United States, 91505
2
ImClone Investigational Site
Los Angeles, California, United States, 90095
3
ImClone Investigational Site
San Francisco, California, United States, 94115
4
ImClone Investigational Site
Jacksonville, Florida, United States, 32207