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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Malignancies

Treatments: Drug: ZD4054 (Zibotentan)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00997945

D4320C00041

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

1

Experimental group

Description:

ZD4054 (Zibotentan) 10mg

Treatment:

Drug: ZD4054 (Zibotentan)