Back to resultsSafety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
Primary Purpose
Cancer, Advanced Hepatocellular Carcinoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AZD8055
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring mTor Kinase Inhibitor, Phase I/II, Dose escalation, Hepatocellular carcinoma (HCC), Asia, HCC, Safety and pharmacokinetics
Eligibility 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.
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AZD8055
Arm Description
Dose escalation
Outcomes
Primary Outcome Measures
Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination)
Evaluate the pharmacokinetics of AZD8055 following both single and multiple dosing
Secondary Outcome Measures
To make a preliminary assessment of efficacy
To investigate the possible relationship between plasma concentration of AZD8055 concentrations and the extent of liver impairment.
Evaluate the change in Phosphorylation levels of certain biomarkers before and after treatment with AZD8055
To collect and store DNA for future exploratory research that may influence response to AZD8055
May not be reported in the CSR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00999882
Brief Title
Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
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 Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Advanced Hepatocellular Carcinoma
Keywords
mTor Kinase Inhibitor, Phase I/II, Dose escalation, Hepatocellular carcinoma (HCC), Asia, HCC, Safety and pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD8055
Arm Type
Experimental
Arm Description
Dose escalation
Intervention Type
Drug
Intervention Name(s)
AZD8055
Intervention Description
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 Measure Information:
Title
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
Title
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 Measure Information:
Title
To make a preliminary assessment of efficacy
Time Frame
Every 4 weeks
Title
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
Title
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
Title
To collect and store DNA for future exploratory research that may influence response to AZD8055
Description
May not be reported in the CSR
Time Frame
Blood sample on Day 1 or at any other visit during study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigette Ma
Organizational Affiliation
Prince of Wales Hospital, HongKong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian Smith
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
Seongnam
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
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