10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies
NCT ID: NCT00997945
Last Updated: 2011-05-19
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
15 participants
INTERVENTIONAL
2009-10-31
2011-04-30
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
BASIC_SCIENCE
NONE
Study Groups
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1
ZD4054 (Zibotentan) 10mg
ZD4054 (Zibotentan)
10 mg ZD4054 (Zibotentan) once daily on Day1, Day4 to Day15
Interventions
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ZD4054 (Zibotentan)
10 mg ZD4054 (Zibotentan) once daily on Day1, Day4 to Day15
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological and/or cytological confirmed advanced solid malignancies
* WHO performance status\<2
Exclusion Criteria
* ALT or AST³2.5 ´ULRR. If liver metastases are present ALT or AST more than 5times ULRR, Serum bilirubin \> 1.5 x ULRR, Serum creatinine\>1.5 x ULRR or creatinine clearance of \<50mL/min calculated by Cockroft-Gault
* Recent (\<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed, Radical radiotherapy within the previous 4 weeks, or unresolved acute or subacute toxicities from prior radiotherapy
50 Years
MALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Li Jin
Role: PRINCIPAL_INVESTIGATOR
The Cancer Hospital Affiliated Fudan University
Helen Lin
Role: STUDY_DIRECTOR
AstraZeneca China MC
Locations
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Research Site
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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D4320C00041
Identifier Type: -
Identifier Source: org_study_id
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