Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
NCT ID: NCT00999882
Last Updated: 2012-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2009-10-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AZD8055
Dose escalation
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Brigette Ma
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital, HongKong
Ian Smith
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Hong Kong, , Hong Kong
Research Site
Seongnam-si, Gyeonggi-do, South Korea
Research Site
Seoul, , South Korea
Countries
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Other Identifiers
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D1600C00014
Identifier Type: -
Identifier Source: org_study_id
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