Hepatocellular Carcinoma (HCC)_Torisel_

NCT01251458 | Completed Phase 1

• 1 other identifier: HCC022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inoperable HCC

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (7)

• • 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

Study Arms (1)

Torisel

EXPERIMENTAL

Drug: Torisel

Interventions

Torisel DRUG

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

Torisel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

temsirolimus

Study Officials

• Winnie Yeo, MD, FRCP

  Department of Clinical Oncology, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comprehensive Clinical Trial Unit

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: October 1, 2009
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-01

Locations

HK (1)