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This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patupilone only | Experimental | Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin |
|
| Carboplatin alone | Active Comparator | Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patupilone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6) | Every 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations | Every 6 weeks | |
| Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors) |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmeceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States | ||
| Associates in Oncology |
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| Label | URL |
|---|---|
| Results can be found for CEPO906A2105 on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C093788 | epothilone B |
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| Every 6 weeks |
| Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response | Every 6 weeks |
| Pharmacokinetic profile of patupilone combined with carboplatin | First 6 weeks (cycle 1 & 2 only) |
| Relationship between pharmacokinetics and clinical outcome | Every 6 weeks during cycle 1 & cycle 2 |
| Rockville |
| Maryland |
| 20850 |
| United States |
| Wertz Clinical Cancer Center (Wayne State University) | Detroit | Michigan | 48201 | United States |
| Siteman Cancer Center (Washington University School of Medicine) | St Louis | Missouri | 63110-1093 | United States |
| Cancer Research and Treatment Center (University of New Mexico) | Albuquerque | New Mexico | 87131 | United States |