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This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Normal liver function) | Experimental |
| |
| Arm B (Mild liver dysfunction) | Experimental |
| |
| Arm C (Moderate liver dysfunction) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patupilone/EPO906 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite | After completion of the study (approximately 6 weeks from treatment) | |
| To determine the maximum tolerated dose of patupilone in patients with hepatic impairment | After completion of the study (approximately 6 weeks from treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics | After completion of the study (approximately 6 weeks from treatment) | |
| Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values |
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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 |
|---|---|---|---|---|---|---|
| University of California San Diego/Moores Cancer Center | La Jolla | California | 92093-0987 | United States | ||
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| Label | URL |
|---|---|
| Results can be found for CEPO906A2121 on the Novartis Clinical Trials 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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| After completion of the study (approximately 6 weeks from treatment) |
| To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks | After completion of the study (approximately 6 weeks from treatment) |
| Cancer Research and Treatment Center |
| Albuquerque |
| New Mexico |
| 87131-5636 |
| United States |
| Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science | San Antonio | Texas | 78229 | United States |
| South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |