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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00997945
First received: October 19, 2009
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Advanced Solid Malignancies
Drug: ZD4054 (Zibotentan)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ZD4054 (Zibotentan) 10mg
Drug: ZD4054 (Zibotentan)
10 mg ZD4054 (Zibotentan) once daily on Day1, Day4 to Day15
Other Name: Zibotentan

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997945

Locations
China, Shanghai
Research Site
Shanghai, Shanghai, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Li Jin The Cancer Hospital Affiliated Fudan University
Study Director: Helen Lin AstraZeneca China MC
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00997945     History of Changes
Other Study ID Numbers: D4320C00041
Study First Received: October 19, 2009
Last Updated: May 18, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I, advanced solid malignancies, advance solid tumour
advanced cancer
ZD4054 (Zibotentan)
china
PK
pharmacokinetics

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014