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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00997945
Other study ID # D4320C00041
Secondary ID
Status Completed
Phase Phase 1
First received October 19, 2009
Last updated May 18, 2011
Start date October 2009
Est. completion date April 2011

Study information

Verified date May 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date April 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Research Site Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 Yes
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