Hepatocellular Carcinoma (HCC)_Torisel_

Inoperable HCC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251458
• Other study ID #: HCC022
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 1, 2010
• Last updated: September 27, 2016
• Start date: October 2009
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Inoperable HCC

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No
Secondary	• To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC		2 Years	No
Secondary	• To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®		4 Years	No
Secondary	• To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel®		2 years	No
Secondary	• To determine the response rate (CR and PR) based on RECIST criteria		2 years	No
Secondary	• To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD = 12 weeks)		2 years	No
Secondary	• To determine duration of response (DR)		2 years	No
Secondary	• To determine overall survival (OS)		4 years	No