A Study of Vinflunine in Patients With Gastric Cancer

Phase 2

Terminated

• Conditions: Stomach Cancer
• Interventions: Drug: Vinflunine

• Registration Number: NCT00359476
• Lead Sponsor: Bristol-Myers Squibb

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 fluoropyrimidine or taxane-containing chemotherapy regimen. The safety of this treatment will also be studied.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-01
• Study First Submitted QC: 2006-08-01
• Study First Posted: 2006-08-02
• Study Start: 2007-03
• Primary Completion: 2007-10
• Study Completion: 2007-11
• Status Verified: 2007-12
• Disposition First Submitted: 2010-02-27
• Disposition First Submitted QC: 2010-02-27
• Last Update Submitted: 2010-02-27
• Disposition First Posted: 2010-03-02
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• 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 Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Vinflunine	-

Primary Outcome Measures

Name	Time	Method
The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST]	throughout the study

Secondary Outcome Measures

Name	Time	Method
Estimation of the progression free survival and overall survival	At the end of the study
The estimation of the disease control rate	At the end of the study
The time to response and the duration of response	At the end of the study
The evaluation of the safety profile of vinflunine	At the end of the study

Trial Locations

Locations (1)

Local Institution; 🇵🇭 Quezon City, Philippines