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Hepatocellular Carcinoma (HCC)_Torisel_

Primary Purpose

Inoperable HCC

Status

Completed

Phase

Phase 1

Locations

Hong Kong

Study Type

Interventional

Intervention

Torisel

About this trial

This is an interventional treatment trial for Inoperable HCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Clinical Oncology, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Torisel

Arm Description

Outcomes

Primary Outcome Measures

• 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)

Secondary Outcome Measures

• To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC

• To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®

• To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel®

• To determine the response rate (CR and PR) based on RECIST criteria

• To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks)

• To determine duration of response (DR)

• To determine overall survival (OS)

Full Information

NCT ID

NCT01251458

First Posted

December 1, 2010

Last Updated

September 27, 2016

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT01251458

Brief Title

Hepatocellular Carcinoma (HCC)_Torisel_

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inoperable HCC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Torisel

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Torisel

Intervention Description

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

Primary Outcome Measure Information:

Title

• 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)

Time Frame

2 years

Secondary Outcome Measure Information:

Title

• To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC

Time Frame

2 Years

Title

• To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®

Time Frame

4 Years

Title

• To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel®

Time Frame

2 years

Title

• To determine the response rate (CR and PR) based on RECIST criteria

Time Frame

2 years

Title

• To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks)

Time Frame

2 years

Title

• To determine duration of response (DR)

Time Frame

2 years

Title

• To determine overall survival (OS)

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Winnie Yeo, MD, FRCP

Organizational Affiliation

Department of Clinical Oncology, The Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Oncology, Prince of Wales Hospital

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Hepatocellular Carcinoma (HCC)_Torisel_

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