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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00999882
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Cancer Advanced Hepatocellular Carcinoma Drug: AZD8055 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. To make a preliminary assessment of efficacy [ Time Frame: Every 4 weeks ]
  2. To investigate the possible relationship between plasma concentration of AZD8055 concentrations and the extent of liver impairment. [ Time Frame: 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 ]
  3. Evaluate the change in Phosphorylation levels of certain biomarkers before and after treatment with AZD8055 [ Time Frame: Blood samples x 3 times on Day 1 of the first cycle ]
  4. To collect and store DNA for future exploratory research that may influence response to AZD8055 [ Time Frame: Blood sample on Day 1 or at any other visit during study ]
    May not be reported in the CSR

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00999882

Hong Kong
Research Site
Hong Kong, Hong Kong
Korea, Republic of
Research Site
Seongnam, Gyeonggi-do, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Principal Investigator: Brigette Ma Prince of Wales Hospital, HongKong
Study Director: Ian Smith AstraZeneca

Responsible Party: AstraZeneca Identifier: NCT00999882     History of Changes
Other Study ID Numbers: D1600C00014
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by AstraZeneca:
mTor Kinase Inhibitor
Phase I/II
Dose escalation
Hepatocellular carcinoma (HCC)
Safety and pharmacokinetics

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases