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

This study has been completed.

First Received on March 3, 2003. Last Updated on January 25, 2011 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00055471

Purpose

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

Condition	Intervention	Phase
Prostatic Neoplasms Metastases, Neoplasm	Drug: ZD4054	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: ZD4054

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Maximum Well-Tolerated Dose (MWTD) [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total Prostate Specific Antigen (PSA) Concentration [ Time Frame: Baseline to Day 15 ] [ Designated as safety issue: No ]
Change in Total Prostate Specific Antigen (PSA) [ Time Frame: Baseline to Day 15 ] [ Designated as safety issue: No ]
Change in Serum Concentration of Bone Alkaline Phosphatase (ALP) [ Time Frame: Baseline to Day 15 ] [ Designated as safety issue: No ]
Change in Serum Concentration of Procollagen Type I N Propeptide (PINP) [ Time Frame: Baseline to Day 15 ] [ Designated as safety issue: No ]
Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx) [ Time Frame: Baseline to Day 15 ] [ Designated as safety issue: No ]
Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) [ Time Frame: Baseline to Day 15 ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	June 2003
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 2 x 10 mg + 1 x 2.5 mg oral tablets once daily	Drug: ZD4054 Other Name: Zibotentan
Experimental: 2 1 x 10 mg oral tablet once daily	Drug: ZD4054 Other Name: Zibotentan
Experimental: 3 1 x 10 mg + 2 x 2.5 mg oral tablets once daily	Drug: ZD4054 Other Name: Zibotentan

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055471

Locations

United States, Ohio
Research Site
Cleveland, Ohio, United States, 44195
United States, Wisconsin
Research Site
Madison, Wisconsin, United States

Sponsors and Collaborators

AstraZeneca

More Information

Additional Information:

AstraZeneca Information Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AstraZeneca, MSD
ClinicalTrials.gov Identifier:	NCT00055471 History of Changes
Other Study ID Numbers:	4054IL/0004
Study First Received:	March 3, 2003
Last Updated:	January 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

prostate cancer
Metastatic prostate cancer
bone metastases

Additional relevant MeSH terms:

Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Pathologic Processes

Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012