Status:
TERMINATED
A Study of Vinflunine in Patients With Gastric Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Stomach Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to learn if vinflunine can shrink or slow the growth of cancer in patients with advanced or metastatic stomach cancer who have progressed on a prior treatment with a fluor...
Eligibility Criteria
Inclusion
- Patients with locally advanced or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction who have progressed on a fluoropyrimidine or taxane-containing regimen in any combination in one prior first line treatment.
- EGOC performance status of 0,1 or 2
- Men and women, 18 years of age and older
Exclusion
- Patients having received more than one previous systemic chemotherapy regimen in any setting.
- Major abdominal surgery within 2 months or any other surgery under general anesthesia within 4 weeks
- Unresolved occlusive or sub-occlusive intestinal disease or any significant chronic intestinal disease (e.g. ulcerative colitis)
- Prior radiation to \>=30% of the bone marrow and/or radiation within 4 weeks prior to enrollment
- Acute or chronic hepatitis
- Known HIV infection
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms
- A history of additional risk factors for Torsade de Pointes (e.g., heart failure hypokalemia, family history of Long QT Syndrome)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00359476
Start Date
March 1 2007
End Date
November 1 2007
Last Update
March 2 2010
Active Locations (6)
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1
Local Institution
Kampung Baharu Nilai, Negeri Sembilan, Malaysia, 71800
2
Local Institution
Quezon City, Philippines, 1102
3
Local Institution
Suwon, Gyeonggi-do, South Korea, 442-723
4
Local Institution
Gyeonggi-do, South Korea, 410-769