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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00999882
First received: October 13, 2009
Last updated: July 9, 2012
Last verified: July 2012
History of Changes

October 13, 2009
July 9, 2012
October 2009
December 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination) [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00999882 on ClinicalTrials.gov Archive Site
  • To make a preliminary assessment of efficacy [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    May not be reported in the CSR
  • To make a preliminary assessment of efficacy [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 and 3 times on the last day of the expansion phase (Part B) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
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

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Advanced Hepatocellular Carcinoma
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.
Experimental: AZD8055
Dose escalation
Intervention: Drug: AZD8055
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   Korea, Republic of
 
NCT00999882
D1600C00014
Yes
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Brigette Ma Prince of Wales Hospital, HongKong
Study Director: Ian Smith AstraZeneca
AstraZeneca
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP