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

ZD4054 (Zibotentan)

Li Jin

Helen Lin

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.

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

AstraZeneca

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Docetaxel

Tubulin Modulators

Antimitotic Agents

Part A (dose-finding): ZD4054 (Zibotentan) 10 mg oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle

Part A (dose-finding): ZD4054 (Zibotentan) 15 mg oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle

Part B (randomised, placebo-controlled): ZD4054 (Zibotentan) Maximum Tolerated Dose (MTD), 15mg, oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle

Part B (randomised, placebo-controlled): Matching placebo oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle

Placebo

AstraZeneca Emerging Oncology Medical Science Director, MD

Two-part, multi-center study design to establish a maximum tolerated dose (MTD) of ZD4054 in combination with docetaxel and to explore its safety, tolerability, pharmacokinetic (PK) profiles and clinical efficacy in patients with metastatic hormone-refractory prostate cancer (HRPC)

Phase I Study of ZD4054 (Zibotentan) and Docetaxel in Patients With Metastatic HRPC

A Phase I Study of ZD4054 (Zibotentan) in Combination With Docetaxel in 2 Parts, an Open-Label, Non-Randomized, Dose-Finding Part and a Double-Blind, Placebo-Controlled, Randomized Dose Expansion Part, in Patients With Metastatic Hormone-Refractory Prostate Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies	NCT00997945	Advanced Solid ...	ZD4054 (Ziboten...	50 Years -	AstraZeneca
Phase I Study of ZD4054 (Zibotentan) and Docetaxel in Patients With Metastatic HRPC	NCT00314782	Prostate Cancer	ZD4054 (Ziboten... Docetaxel Placebo	18 Years -	AstraZeneca

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