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.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00055471

First received: March 3, 2003

Last updated: October 23, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 3, 2003
Last Updated Date	October 23, 2012
Start Date ^ICMJE	June 2003
Primary Completion Date	October 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 31, 2012)	Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline to Day 29. ] [ Designated as safety issue: Yes ] DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00055471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 21, 2012)	Total Prostate Specific Antigen (PSA) Concentration [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ] Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Change in Total Prostate Specific Antigen (PSA) [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ] Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]100 Change in Serum Concentration of Bone Alkaline Phosphatase (ALP) [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ] Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]100 Change in Serum Concentration of Procollagen Type I N Propeptide (PINP) [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ] Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]100 Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx) [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ] Percentage change in serum concentration of C-Terminal Telopeptide of Type I Collagen (CTx) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]100 Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ] Percentage change in urine concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) (nmol BCE/mmol Creatinine) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	Not Provided
Brief Summary	The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Prostatic Neoplasms Metastases, Neoplasm
Intervention ^ICMJE	Drug: ZD4054 10 mg 1 x 10 mg oral tablets once daily Other Name: Zibotentan, Drug: ZD4054 15 mg 1 x 10 mg + 2 x 2.5 mg oral tablets once daily Other Name: Zibotentan Drug: ZD4054 22.5 mg 2 x 10 mg + 2 x 2.5 mg oral tablets once daily Other Name: Zibotentan
Study Arm (s)	Experimental: ZD4054 10 mg 1 x 10 mg oral tablets once daily Intervention: Drug: ZD4054 10 mg Experimental: ZD4054 15 mg 1 x 10 mg + 2 x 2.5 mg oral tablets once daily Intervention: Drug: ZD4054 15 mg Experimental: ZD4054 22.5 mg 2 x 10 mg + 1 x 2.5 mg oral tablets once daily Intervention: Drug: ZD4054 22.5 mg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	22
Completion Date	October 2005
Primary Completion Date	October 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00055471
Other Study ID Numbers ^ICMJE	4054IL/0004
Has Data Monitoring Committee	Not Provided
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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