Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Cancer

Advanced Hepatocellular Carcinoma

Treatments

Drug: AZD8055

Study type

Interventional

Funder types

Industry

Identifiers

NCT00999882

D1600C00014

Details and patient eligibility

About

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 collecting data about how hepatocellular carcinoma responds to the drug.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.