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

Phase 1

Completed

• Conditions: Cancer; Advanced Hepatocellular Carcinoma
• Interventions: Drug: AZD8055

• Registration Number: NCT00999882
• Lead Sponsor: AstraZeneca

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 collecting data about how hepatocellular carcinoma responds to the drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD8055	AZD8055	Dose escalation

Primary Outcome Measures

Name	Time	Method
Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination)	Every week for Cycle 1 and 2, every 2 weeks from cycle 3 onwards, every 4 weeks from cycle 7 onwards
Evaluate the pharmacokinetics of AZD8055 following both single and multiple dosing	Blood samples on 6 occasions during the first Cycle of the study (28 days)

Secondary Outcome Measures

Name	Time	Method
Evaluate the change in Phosphorylation levels of certain biomarkers before and after treatment with AZD8055	Blood samples x 3 times on Day 1 of the first cycle
To collect and store DNA for future exploratory research that may influence response to AZD8055	Blood sample on Day 1 or at any other visit during study	May not be reported in the CSR
To make a preliminary assessment of efficacy	Every 4 weeks
To investigate the possible relationship between plasma concentration of AZD8055 concentrations and the extent of liver impairment.	During Cycle 1 of the study - blood samples before study treatment and then on Day 1, 3, 10, 17, 24, 30 and then on day 1 of every cycle

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of