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This study will evaluate the safety, efficacy, and activity of patupilone in patients with advanced unresectable and/or metastatic hepatocellular carcinoma based on tumor response using modified RECIST criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patupilone | Experimental | was administered at 10 mg/m2, as a single intravenous infusion over 20 minutes, once every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patupilone | Drug | Patupilone was in dosage strength of 10 mg/4 mL as a clear, colorless concentrate for solution for injection in individual 10 mL glass vials |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) | at screening and at completion of every 6 weeks prior to the next dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | at screening and at completion of every 6 weeks prior to the next dose administration | |
| Overall survival | at screening and at completion of every 6 weeks prior to the next dose administration |
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Inclusion criteria:
- Hepatocellular carcinoma patients with at least 1 previously un-irradiated, measurable lesion without any systemic single agent or combination chemotherapy. Previous local therapy is allowed.
Exclusion criteria:
Additional protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | San Francisco | California | 94115 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23509629 | Result | Zhou Q, Wong CH, Lau CP, Hui CW, Lui VW, Chan SL, Yeo W. Enhanced Antitumor Activity with Combining Effect of mTOR Inhibition and Microtubule Stabilization in Hepatocellular Carcinoma. Int J Hepatol. 2013;2013:103830. doi: 10.1155/2013/103830. Epub 2013 Feb 20. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C093788 | epothilone B |
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|
| Hong Kong |
| Shatin, NT |
| Hong Kong |
| Novartis Investigative Site | Hong Kong | Hong Kong |
| Novartis Investigative Site | Seoul | Korea | 110 744 | South Korea |
| Novartis Investigative Site | Seoul | 738-736 | South Korea |
| Novartis Investigative Site | Taipei | Taiwan ROC | 100 | Taiwan |
| Novartis Investigative Site | Tai Chung Municipality | Taiwan |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |