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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2010

Interventions

  • Drug: ZD4054 (Zibotentan)
    • 10 mg ZD4054 (Zibotentan) once daily on Day1, Day4 to Day15

Arms, Groups and Cohorts

  • Experimental: 1
    • ZD4054 (Zibotentan) 10mg

Clinical Trial Outcome Measures

Primary 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

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • MSD, AstraZeneca
  • Overall Official(s)
    • Li Jin, Principal Investigator, The Cancer Hospital Affiliated Fudan University
    • Helen Lin, Study Director, AstraZeneca China MC

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