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NCT Number: NCT00997945

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

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.

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Key information

Conditions

Advanced Solid Malignancies

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZD4054 (Zibotentan)

Drug

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

Other names: Zibotentan

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

    Time frame: 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

    Time frame: Safety assessments to be taken until Day 16 (while patient remains on study treatment), then every 8 weeks until treatment discontinuation

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Oct 20, 2009
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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