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10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997945
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 19, 2009
First Posted Date  ICMJE October 20, 2009
Last Update Posted Date May 19, 2011
Study Start Date  ICMJE October 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2010)		 To assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies [ Time Frame: PK samples will be taken until Day 16 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2009)		 To assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 in male, elderly Chinese patients with advanced solid malignancies [ Time Frame: PK samples will be taken until Day 16 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2010)		 To assess the safety and tolerability of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies [ Time Frame: Safety assessments to be taken until Day 16 (while patient remains on study treatment), then every 8 weeks until treatment discontinuation ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2009)		 To assess the safety and tolerability of single and multiple doses of 10mg ZD4054 in male, elderly Chinese patients with advanced solid malignancies [ Time Frame: Safety assessments to be taken until Day 16 (while patient remains on study treatment), then every 8 weeks until treatment discontinuation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Advanced Solid Malignancies
Intervention  ICMJE Drug: ZD4054 (Zibotentan)
10 mg ZD4054 (Zibotentan) once daily on Day1, Day4 to Day15
Other Name: Zibotentan
Study Arms  ICMJE Experimental: 1
ZD4054 (Zibotentan) 10mg
Intervention: Drug: ZD4054 (Zibotentan)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2009)		 15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of informed consent
  • Histological and/or cytological confirmed advanced solid malignancies
  • WHO performance status<2

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00997945
Other Study ID Numbers  ICMJE D4320C00041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MSD, AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li Jin The Cancer Hospital Affiliated Fudan University
Study Director: Helen Lin AstraZeneca China MC
PRS Account AstraZeneca
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP