Know Cancer

or
forgot password

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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Inoperable HCC

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

• 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)

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Winnie Yeo, MD, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Clinical Oncology, The Chinese University of Hong Kong

Authority:

Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:

HCC022

NCT ID:

NCT01251458

Start Date:

October 2009

Completion Date:

October 2013

Related Keywords:

  • Inoperable HCC
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location