Safety, Tolerability, pharmacokinetics (PK) and preliminary efficacy of Tor Kinase inhibitor in liver cancer patients
Study identifier:D1600C00014
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD8055
Sex
All
Actual Enrollment
26
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Oct 2009
Primary Completion Date: 01 Dec 2011
Study Completion Date: 01 Dec 2011
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD8055 Dose escalation | 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. |
Contacts
Investigators
Principal Investigator
Brigette Ma
Prince of Wales Hospital, HongKong
