A Study of Vinflunine in Patients With Gastric Cancer

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

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.

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)