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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999882
• Other study ID #: D1600C00014
• Status: Completed
• Phase: Phase 1
• First received: October 13, 2009
• Last updated: July 9, 2012
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of HealthHong Kong: Ethics CommitteeKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Cancer
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• AZD8055
Dose escalation phase: Tablet taken orally, a single dose of AZD8055 on Day 1, followed by twice daily continuous dosing from Day 3 onwards, till discontinuation or withdrawal.Expansion phase: twice daily continuous dosing from Day 1 onwards till discontinuation or withdrawal.

Locations

Country	Name	City	State
Hong Kong	Research Site	Hong Kong
Korea, Republic of	Research Site	Seongnam	Gyeonggi-do
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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)	Yes
Secondary	To make a preliminary assessment of efficacy		Every 4 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	To collect and store DNA for future exploratory research that may influence response to AZD8055	May not be reported in the CSR	Blood sample on Day 1 or at any other visit during study	No