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Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.
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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 |
|---|---|---|
| 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 | at completion of the study | |
| To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks | at completion of the study |
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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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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C093788 | epothilone B |
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| Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science Center |
| San Antonio |
| Texas |
| 78229 |
| United States |
| South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |