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

Phase 2

Completed

• Conditions: Prostatic Neoplasms; Metastases, Neoplasm
• Interventions: Drug: ZD4054 10 mg; Drug: ZD4054 15 mg; Drug: ZD4054 22.5 mg

• Registration Number: NCT00055471
• Lead Sponsor: AstraZeneca

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 available

Study Timeline

• Study First Submitted: 2003-03-03
• Study First Submitted QC: 2003-03-03
• Study First Posted: 2003-03-04
• Study Start: 2003-06
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Results First Submitted: 2011-03-29
• Results First Submitted QC: 2012-07-31
• Results First Posted: 2012-08-31
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-23
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ZD4054 10 mg	ZD4054 10 mg	1 x 10 mg oral tablets once daily
ZD4054 15 mg	ZD4054 15 mg	1 x 10 mg + 2 x 2.5 mg oral tablets once daily
ZD4054 22.5 mg	ZD4054 22.5 mg	2 x 10 mg + 1 x 2.5 mg oral tablets once daily

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities (DLTs)	Baseline to Day 29.	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.

Secondary Outcome Measures

Name	Time	Method
Total Prostate Specific Antigen (PSA) Concentration	Baseline to Day 15.	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)	Baseline to Day 15.	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)	Baseline to Day 15.	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)	Baseline to Day 15.	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)	Baseline to Day 15.	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)	Baseline to Day 15.	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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Madison, Wisconsin, United States