Trial Information
A Phase I/II, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Tor Kinase Inhibitor (AZD8055) in Asian Patients With Advanced Stage Hepatocellular Carcinoma (HCC) and With Mild or Moderate Hepatic Impairment
Inclusion Criteria:
- Advanced stage Hepatocellular Carcinoma (HCC) confirmed by cytology or histology
- Advanced stage Hepatocellular Carcinoma (HCC) or metastatic Hepatocellular Carcinoma
(HCC) which is inoperable and incurable with standard available treatments
- Relatively good overall health other than cancer (WHO performance status (0-2)
Exclusion Criteria:
- Patients with severe heart conditions, or those who have had heart surgery such as
coronary artery bypass graft within the last 6 months, or patients with uncontrolled
high blood pressure despite medical management.
- Patients must not have received any other anti cancer therapy including TACE within
21 days of entering the trial
- Patients must not have received a liver transplant.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination)
Outcome Time Frame:
Every week for Cycle 1 and 2, every 2 weeks from cycle 3 onwards, every 4 weeks from cycle 7 onwards
Safety Issue:
Yes
Principal Investigator
Brigette Ma
Investigator Role:
Principal Investigator
Investigator Affiliation:
Prince of Wales Hospital, HongKong
Authority:
Hong Kong: Department of Health
Study ID:
D1600C00014
NCT ID:
NCT00999882
Start Date:
October 2009
Completion Date:
December 2011
Related Keywords:
- Cancer
- Advanced Hepatocellular Carcinoma
- mTor Kinase Inhibitor
- Phase I/II
- Dose escalation
- Hepatocellular carcinoma (HCC)
- Asia
- HCC
- Safety and pharmacokinetics
- Carcinoma
- Carcinoma, Hepatocellular