Hepatocellular Carcinoma (HCC)_Torisel_

Phase 1

Completed

• Conditions: Inoperable HCC
• Interventions: Drug: Torisel

• Registration Number: NCT01251458
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Histologically confirmed hepatocellular carcinoma that is not amenable to curative resection
• measurable disease
• Age >=18 years.
• Life expectancy of greater than 12 weeks.
• ECOG performance status <= 2
• Prior systemic therapy for HCC is allowed
• Adequate haematologic, renal and hepatic function
• Absence of cirrhosis or Child's A cirrhosis
• Fasting total cholesterol <9.1 mmol/liter and fasting triglyceride level <4.5 mmol/liter)

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Exclusion Criteria

• Patients who have had systemic therapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
• Patients receiving any other investigational agents concurrently.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Uncontrolled intercurrent diseases such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Torisel	Torisel	-

Primary Outcome Measures

Name	Time	Method
• 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

Secondary Outcome Measures

Name	Time	Method
• To determine duration of response (DR)	2 years
• 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 the response rate (CR and PR) based on RECIST criteria	2 years
• To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®	4 Years
• To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel®	2 years
• To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks)	2 years
• To determine overall survival (OS)	4 years

Trial Locations

Locations (1)

Department of Clinical Oncology, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong