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This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Torisel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Torisel | Drug | Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| • To establish the maximum tolerated dose (MTD) and a suitable dose for Phase II evaluation of Torisel® given as a weekly dose in patients with advanced hepatocellular carcinoma (HCC) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| • To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC | 2 Years | |
| • To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel® |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Winnie Yeo, MD, FRCP | Department of Clinical Oncology, The Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology, Prince of Wales Hospital | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| C401859 | temsirolimus |
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| 4 Years |
| • To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel® | 2 years |
| • To determine the response rate (CR and PR) based on RECIST criteria | 2 years |
| • To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks) | 2 years |
| • To determine duration of response (DR) | 2 years |
| • To determine overall survival (OS) | 4 years |