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Prostate

D4320C00033. A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 in Combination with Docetaxel in Comparison with Docetaxel in Patients with Metastatic Hormone-resistant Prostate Cancer

Unique Data Set IDProstat_AstraZe_2008_104
DownloadableYes
SponsorAstraZenecaData ProviderAstraZenecaTotal Study Enrolled Patients1494Comparator (Control) Arm Enrolled Patients528RandomizationYesClinicalTrial.gov IDNCT00617669ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00617669?term=NCT00617669&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeOther

Clinical Trial Title

D4320C00033. A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 in Combination with Docetaxel in Comparison with Docetaxel in Patients with Metastatic Hormone-resistant Prostate Cancer

Trial Summary and Conditions

This dataset was used as validation data for the Prostate Cancer DREAM Challenge. To view the curated training dataset, which includes 3 mCRPC datasets from ProjectDataSphere.org, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/149

Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone. ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel. All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies. Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour. No patients will be deprived of standard prostate cancer therapy. Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment

Data Summary

All data colleted from comparator arm

Study Objectives

Primary objective The primary objective of this study is to determine the effect of ZD4054 in combination with docetaxel on overall survival compared with docetaxel; overall survival is defined as time to death (from randomisation) from any cause. Secondary objectives The secondary objectives of the study are: 1. To assess the effect of ZD4054 in combination with docetaxel on progression free survival compared with docetaxel. 2. To assess the safety and tolerability profile of ZD4054 in combination with docetaxel compared with docetaxel 3. To assess the effect of ZD4054 in combination with docetaxel on skeletal-related events compared with docetaxel 4. To investigate the effect of ZD4054 in combination with docetaxel on time to prostate-specific antigen (PSA) progression compared to docetaxel 5.To assess the effects of ZD4054 in combination with docetaxel on time to pain progression compared with docetaxel 6. To assess the effects of ZD4054 in combination with docetaxel on pain response compared to docetaxel 7. To assess the effect of ZD4054 in combination with docetaxel on Health-related Quality of Life (HRQoL) compared with docetaxel 8. To investigate the effect of ZD4054 in combination with docetaxel on PSA response compared to docetaxel

Outcome Measures

Primary Outcome Measures: Overall SurvivalMedian time (in months) from randomisation until death using the Kaplan-Meier method. Secondary Outcome Measures: Progression Free Survival Incidence of Skeletal Related Events Time to Prostate-specific Antigen (PSA) Progression Time to Pain Progression Pain Response Health Related Quality of Life PSA Response .

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Zibotentan CSP D4320C00033 With Redactions_Redacted.pdf

CRF: aCRF D4320C00033.docx

DATA DICTIONARY: RDB Standards - D4320C00015 and D4320C00033.xlsx

DATA (COMPARATOR ARM): D4320C00033 De-Identified RDB Data.zip