Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
Lead Sponsor:
AstraZeneca
Conditions:
Cancer
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of the study is to establish a safe dose of AZD8055 in patients with mild or moderate liver disease by providing information on any potential side effects this drug may cause and coll...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00999882
Start Date
October 1 2009
End Date
December 1 2011
Last Update
July 10 2012
Active Locations (3)
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1
Research Site
Hong Kong, Hong Kong
2
Research Site
Seongnam-si, Gyeonggi-do, South Korea
3
Research Site
Seoul, South Korea