Stomach Cancer
Conditions
Keywords
Locally advanced/metastatic gastric adenocarcinoma, adenocarcinoma-gastroesophageal junction, Gastric Adenocarcinoma
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.
Interventions
DRUGVinflunine
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST] | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Malaysia, Philippines, South Korea
Outcome results
None listed