This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
• 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)
Time frame: 2 years
• To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC
Time frame: 2 Years
• To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®
Time frame: 4 Years
• To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel®
Time frame: 2 years
• To determine the response rate (CR and PR) based on RECIST criteria
Time frame: 2 years
• To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks)
Time frame: 2 years
• To determine duration of response (DR)
Time frame: 2 years
• To determine overall survival (OS)
Time frame: 4 years
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