ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA) - Full Text View

Purpose

This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).

Condition	Intervention	Phase
Prostate Cancer	Drug: ZD4054 15 mg Drug: Placebo Drug: ZD4054 10 mg	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Cancer Prostate Cancer Prostate Cancer Screening

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to Progression (TTP) [ Time Frame: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008). ] [ Designated as safety issue: No ]
Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.

Secondary Outcome Measures:

Time to Death [ Time Frame: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008). ] [ Designated as safety issue: No ]
Median time (in days) from randomisation until death using the Kaplan-Meier method.
Change in Total Prostate Specific Antigen (PSA) Over Time [ Time Frame: Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006). ] [ Designated as safety issue: No ]
Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.
Objective Response Rate (ORR) [ Time Frame: For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006). ] [ Designated as safety issue: No ]
Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST. Objective Response Rate (ORR) is defined as the percentage of patients with OR.
Change in Number of Bone Metastases Over Time [ Time Frame: Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days. ] [ Designated as safety issue: No ]
Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.


Enrollment:	447
Study Start Date:	July 2004
Study Completion Date:	August 2011
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Matching placebo oral tablet once daily, with best supportive care	Drug: Placebo
Experimental: ZD4054 10 mg ZD4054 10 mg oral tablet once daily, with best supportive care	Drug: ZD4054 10 mg 10mg oral tablet once daily Other Name: (Zibotentan)
Experimental: ZD4054 15 mg ZD4054 15 mg oral tablet once daily, with best supportive care	Drug: ZD4054 15 mg 15 mg oral tablet once daily Other Name: Zibotentan

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Surgically or medically castrated
Bone metastasis
Rising PSA

Exclusion Criteria:

Opiate use
Prior chemotherapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090363

Show 60 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca Emerging Oncology Medical Science Director, MD	AstraZeneca

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

James ND, Caty A, Borre M, Zonnenberg BA, Beuzeboc P, Morris T, Phung D, Dawson NA. Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: a double-blind, placebo-controlled, randomised, phase 2 trial. Eur Urol. 2009 May;55(5):1112-23. doi: 10.1016/j.eururo.2008.11.002. Epub 2008 Nov 29.


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00090363 History of Changes
Obsolete Identifiers:	NCT00107146
Other Study ID Numbers:	D4320C00006 Trial 6 ZD4054
Study First Received:	August 25, 2004
Results First Received:	April 26, 2012
Last Updated:	January 3, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:


rising PSA bone metastases Clinical study pain-free or mildly symptomatic

Additional relevant MeSH terms:


Prostatic Neoplasms Neoplasm Metastasis Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site	Neoplasms Genital Diseases, Male Prostatic Diseases Neoplastic Processes Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2016