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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinflunine | Drug | solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration |
|
| Measure | Description | 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Kampung Baharu Nilai | Negeri Sembilan | 71800 | Malaysia | ||
| Local Institution |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C111217 | vinflunine |
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| 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 |
| Quezon City |
| 1102 |
| Philippines |
| Local Institution | Suwon | Gyeonggi-do | 442-723 | South Korea |
| Local Institution | Gyeonggi-do | 410-769 | South Korea |
| Local Institution | Seoul | 120-752 | South Korea |
| Local Institution | Seoul | 136-705 | South Korea |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |