Hepatocellular Carcinoma (HCC)_Torisel_

Phase I/II Study of Temsirolimus (Torisel®) as Novel Therapeutic Drug for Patients With Unresectable Hepatocellular Carcinoma (HCC)- A Correlative Study With Stathmin Over-expression

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

Study Overview

• Status: Completed
• Conditions: Inoperable HCC
• Intervention / Treatment: Drug: Torisel

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Clinical Oncology, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Torisel	Drug: Torisel; Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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®	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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Winnie Yeo, MD, FRCP, Department of Clinical Oncology, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 1, 2010
• First Submitted That Met QC Criteria: December 1, 2010
• First Posted (Estimate): December 2, 2010

Study Record Updates

• Last Update Posted (Estimate): September 28, 2016
• Last Update Submitted That Met QC Criteria: September 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: HCC022