Status:
COMPLETED
10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Solid Malignancies
Eligibility:
MALE
50+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies.
Eligibility Criteria
Inclusion
- Provision of informed consent
- Histological and/or cytological confirmed advanced solid malignancies
- WHO performance status\<2
Exclusion
- History of significant gastrointestinal impairment, as judged by the investigator, that could significantly affect the absorption of ZD4054 (Zibotentan) , including the ability to swallow the tablet whole.
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00997945
Start Date
October 1 2009
End Date
April 1 2011
Last Update
May 19 2011
Active Locations (1)
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1
Research Site
Shanghai, Shanghai Municipality, China