10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies
A Phase I, Open-label, Single-arm Study to Determine the Single and Multiple Dose Pharmacokinetics of 10mg ZD4054 (Zibotentan) Administered Once Daily in Male, Elderly Chinese Patients With Advanced Solid Malignancies
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 19, 2009
CompletedFirst Posted
Study publicly available on registry
October 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 19, 2011
May 1, 2011
11 months
October 19, 2009
May 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies
PK samples will be taken until Day 16
Secondary Outcomes (1)
To assess the safety and tolerability of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies
Safety assessments to be taken until Day 16 (while patient remains on study treatment), then every 8 weeks until treatment discontinuation
Study Arms (1)
1
EXPERIMENTALZD4054 (Zibotentan) 10mg
Interventions
10 mg ZD4054 (Zibotentan) once daily on Day1, Day4 to Day15
Eligibility Criteria
You may qualify if:
- Provision of informed consent
- Histological and/or cytological confirmed advanced solid malignancies
- WHO performance status\<2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Shanghai, Shanghai Municipality, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Li Jin
The Cancer Hospital Affiliated Fudan University
- STUDY DIRECTOR
Helen Lin
AstraZeneca China MC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 19, 2009
First Posted
October 20, 2009
Study Start
October 1, 2009
Primary Completion
September 1, 2010
Study Completion
April 1, 2011
Last Updated
May 19, 2011
Record last verified: 2011-05