search
Back to results

A Study of Vinflunine in Patients With Gastric Cancer

Primary Purpose

Stomach Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vinflunine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Cancer focused on measuring Locally advanced/metastatic gastric adenocarcinoma, adenocarcinoma-gastroesophageal junction, Gastric Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST]

Secondary Outcome Measures

Estimation of the progression free survival and overall survival
The estimation of the disease control rate
The time to response and the duration of response
The evaluation of the safety profile of vinflunine

Full Information

First Posted
August 1, 2006
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT00359476
Brief Title
A Study of Vinflunine in Patients With Gastric Cancer
Official Title
A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-line Treatment of Patients With Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Cancer
Keywords
Locally advanced/metastatic gastric adenocarcinoma, adenocarcinoma-gastroesophageal junction, Gastric Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vinflunine
Intervention Description
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
Primary Outcome Measure Information:
Title
The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST]
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Estimation of the progression free survival and overall survival
Time Frame
At the end of the study
Title
The estimation of the disease control rate
Time Frame
At the end of the study
Title
The time to response and the duration of response
Time Frame
At the end of the study
Title
The evaluation of the safety profile of vinflunine
Time Frame
At the end of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Suwon-Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-Do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Local Institution
City
Nilai
State/Province
Negeri Sembilan
ZIP/Postal Code
71800
Country
Malaysia
Facility Name
Local Institution
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

A Study of Vinflunine in Patients With Gastric Cancer

We'll reach out to this number within 24 hrs