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A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer

NCT ID: NCT00055471

Last Updated: 2012-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-10-31

Brief Summary

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The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer

Detailed Description

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Conditions

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Prostatic Neoplasms Metastases, Neoplasm

Keywords

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prostate cancer Metastatic prostate cancer bone metastases

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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ZD4054 10 mg

1 x 10 mg oral tablets once daily

Group Type EXPERIMENTAL

ZD4054 10 mg

Intervention Type DRUG

1 x 10 mg oral tablets once daily

ZD4054 15 mg

1 x 10 mg + 2 x 2.5 mg oral tablets once daily

Group Type EXPERIMENTAL

ZD4054 15 mg

Intervention Type DRUG

1 x 10 mg + 2 x 2.5 mg oral tablets once daily

ZD4054 22.5 mg

2 x 10 mg + 1 x 2.5 mg oral tablets once daily

Group Type EXPERIMENTAL

ZD4054 22.5 mg

Intervention Type DRUG

2 x 10 mg + 2 x 2.5 mg oral tablets once daily

Interventions

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ZD4054 10 mg

1 x 10 mg oral tablets once daily

Intervention Type DRUG

ZD4054 15 mg

1 x 10 mg + 2 x 2.5 mg oral tablets once daily

Intervention Type DRUG

ZD4054 22.5 mg

2 x 10 mg + 2 x 2.5 mg oral tablets once daily

Intervention Type DRUG

Other Intervention Names

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Zibotentan, Zibotentan Zibotentan

Eligibility Criteria

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Inclusion Criteria

* Men 18 years \& older
* Confirmed diagnosis of prostate cancer with bone metastases

Exclusion Criteria

* No more than 2 prior chemotherapy regimens
* No radiation, chemotherapy or bisphosphonates in the past 4 weeks
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Cleveland, Ohio, United States

Site Status

Research Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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4054IL/0004

Identifier Type: -

Identifier Source: org_study_id