Hepatocellular Carcinoma (HCC)_Torisel_

NCT ID: NCT01251458

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2016-01-31

Brief Summary

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

Conditions

Inoperable HCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Torisel

Group Type: EXPERIMENTAL

Torisel

Intervention Type: DRUG

Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.

Interventions

Torisel

Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CCTU

Comprehensive Clinical Trial Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Winnie Yeo, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Oncology, The Chinese University of Hong Kong

Locations

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

HCC022

Identifier Type: -

Identifier Source: org_study_id