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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
  Purpose

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 Intervention Phase
Cancer
Advanced Hepatocellular Carcinoma
 Drug: AZD8055
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 26
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999882

Locations
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
AstraZeneca
Investigators
Principal Investigator: Brigette Ma Prince of Wales Hospital, HongKong
Study Director: Ian Smith AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00999882     History of Changes
Other Study ID Numbers: D1600C00014
Study First Received: October 13, 2009
Last Updated: July 9, 2012
Health Authority: Hong Kong: Department of Health
Hong Kong: Ethics Committee
Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013