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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


Phase 1
50 Years
N/A
Not Enrolling
Male
Advanced Solid Malignancies

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

To assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies

Outcome Time Frame:

PK samples will be taken until Day 16

Safety Issue:

No

Principal Investigator

Li Jin

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cancer Hospital Affiliated Fudan University

Authority:

China: Food and Drug Administration

Study ID:

D4320C00041

NCT ID:

NCT00997945

Start Date:

October 2009

Completion Date:

April 2011

Related Keywords:

  • Advanced Solid Malignancies
  • Phase I, advanced solid malignancies, advance solid tumour
  • advanced cancer
  • ZD4054 (Zibotentan)
  • china
  • PK
  • pharmacokinetics
  • Neoplasms

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