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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00997945

Enrollment

Registered

2009-10-20

Start date

2009-10-31

Completion date

2011-04-30

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Malignancies

Keywords

Phase I, advanced solid malignancies, advance solid tumour, advanced cancer, ZD4054 (Zibotentan), china, PK, pharmacokinetics

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.

Interventions

DRUGZD4054 (Zibotentan)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies	PK samples will be taken until Day 16

Secondary

Measure	Time frame
To assess the safety and tolerability of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies	Safety assessments to be taken until Day 16 (while patient remains on study treatment), then every 8 weeks until treatment discontinuation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026