A Study of Vinflunine in Patients With Gastric Cancer

Stomach Cancer Clinical Trial

Official title:

A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-line Treatment of Patients With Gastric Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00359476
• Other study ID #: CA183-023
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: August 1, 2006
• Last updated: February 27, 2010
• Start date: March 2007
• Est. completion date: November 2007

Study information

• Verified date: December 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Korean Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: November 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Cancer
• Stomach Neoplasms

Intervention

Drug:
• Vinflunine
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Gyeonggi-Do
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Suwon-Si	Gyeonggi-Do
Malaysia	Local Institution	Nilai	Negeri Sembilan
Philippines	Local Institution	Quezon City

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Korea, Republic of,  Malaysia,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST]		throughout the study
Secondary	Estimation of the progression free survival and overall survival		At the end of the study
Secondary	The estimation of the disease control rate		At the end of the study
Secondary	The time to response and the duration of response		At the end of the study
Secondary	The evaluation of the safety profile of vinflunine		At the end of the study

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm