Hepatocellular Carcinoma (HCC)_Torisel_
This study is ongoing, but not recruiting participants.
Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01251458
First received: December 1, 2010
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel
| Condition | Intervention | Phase |
|---|---|---|
|
Inoperable HCC |
Drug: Torisel |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Chinese University of Hong Kong:
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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- • To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel® [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
- • To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel® [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- • To determine the response rate (CR and PR) based on RECIST criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- • To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- • To determine duration of response (DR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- • To determine overall survival (OS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Torisel |
Drug: Torisel
Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251458
Locations
| Hong Kong | |
| Department of Clinical Oncology, Prince of Wales Hospital | |
| Hong Kong, Hong Kong | |
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
| Principal Investigator: | Winnie Yeo, MD, FRCP | Department of Clinical Oncology, The Chinese University of Hong Kong |
More Information
No publications provided
| Responsible Party: | CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01251458 History of Changes |
| Other Study ID Numbers: | HCC022 |
| Study First Received: | December 1, 2010 |
| Last Updated: | January 8, 2013 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Sirolimus |
Everolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013