A Study of Vinflunine in Patients With Gastric Cancer

Bristol-Myers Squibb (BMS)

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Stomach Cancer

Treatments

Drug: Vinflunine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00359476

CA183-023

Details and patient eligibility

About

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.

Enrollment

55 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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)