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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00090363
First Posted: August 30, 2004
Last Update Posted: January 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
August 25, 2004
August 30, 2004
April 26, 2012
September 3, 2012
January 8, 2013
July 2004
December 2008   (Final data collection date for primary outcome measure)
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). ]
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.
Not Provided
Complete list of historical versions of study NCT00090363 on ClinicalTrials.gov Archive Site
  • 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). ]
    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). ]
    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). ]
    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. ]
    Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.
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ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
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)
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: ZD4054 15 mg
    15 mg oral tablet once daily
    Other Name: Zibotentan
  • Drug: Placebo
  • Drug: ZD4054 10 mg
    10mg oral tablet once daily
    Other Name: (Zibotentan)
  • Placebo Comparator: Placebo
    Matching placebo oral tablet once daily, with best supportive care
    Intervention: Drug: Placebo
  • Experimental: ZD4054 10 mg
    ZD4054 10 mg oral tablet once daily, with best supportive care
    Intervention: Drug: ZD4054 10 mg
  • Experimental: ZD4054 15 mg
    ZD4054 15 mg oral tablet once daily, with best supportive care
    Intervention: Drug: ZD4054 15 mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
447
August 2011
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Surgically or medically castrated
  • Bone metastasis
  • Rising PSA

Exclusion Criteria:

  • Opiate use
  • Prior chemotherapy
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Denmark,   Finland,   France,   Indonesia,   Netherlands,   Norway,   Poland,   Sweden,   Switzerland,   United Kingdom,   United States
 
 
NCT00090363
D4320C00006
Trial 6
ZD4054
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Emerging Oncology Medical Science Director, MD AstraZeneca
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP