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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00997945

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Malignancies	Drug: ZD4054 (Zibotentan)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official 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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 ZD4054 (Zibotentan) 10mg	Drug: ZD4054 (Zibotentan) 10 mg ZD4054 (Zibotentan) once daily on Day1, Day4 to Day15 Other Names: Zibotentan

Arm

Intervention/Treatment

Experimental: 1

ZD4054 (Zibotentan) 10mg

Drug: ZD4054 (Zibotentan)

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

Other Names:

Zibotentan

Outcome Measures

Primary Outcome Measures

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 Outcome 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 [Safety assessments to be taken until Day 16 (while patient remains on study treatment), then every 8 weeks until treatment discontinuation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts 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