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

Prostatic Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055471
• Other study ID #: 4054IL/0004
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2003
• Last updated: October 23, 2012
• Start date: June 2003
• Est. completion date: October 2005

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastases, Neoplasm
• Neoplasm Metastasis
• Neoplasms
• Prostatic Neoplasms

Intervention

Drug:
• ZD4054 10 mg
1 x 10 mg oral tablets once daily
• ZD4054 15 mg
1 x 10 mg + 2 x 2.5 mg oral tablets once daily
• ZD4054 22.5 mg
2 x 10 mg + 2 x 2.5 mg oral tablets once daily

Locations

Country	Name	City	State
United States	Research Site	Cleveland	Ohio
United States	Research Site	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities (DLTs)	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.	Baseline to Day 29.	Yes
Secondary	Total Prostate Specific Antigen (PSA) Concentration	Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).	Baseline to Day 15.	No
Secondary	Change in Total Prostate Specific Antigen (PSA)	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	Baseline to Day 15.	No
Secondary	Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)	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	Baseline to Day 15.	No
Secondary	Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)	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	Baseline to Day 15.	No
Secondary	Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)	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	Baseline to Day 15.	No
Secondary	Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)	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	Baseline to Day 15.	No

External Links

•   AstraZeneca Information Center