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Prostate

A Phase III, Randomised, Double-blind Study to Assess the Efficacy and Safety of 10 mg ZD4054 versus Placebo in Patients with Hormone-resistant Prostate Cancer and Bone Metastasis who are Pain Free or Mildly Symptomatic

Unique Dataset IDProstat_AstraZe_2009_144
DownloadableYes
SponsorAstraZenecaData ProviderAstraZenecaTotal Study Enrolled Patients594Comparator (Control) Arm Enrolled Patients295RandomizationYesClinicalTrial.gov IDNCT00554229ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/results/NCT00554229?term=zibotentan&rank=4
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugDataset TypeOther

Clinical Trial Title

A Phase III, Randomised, Double-blind Study to Assess the Efficacy and Safety of 10 mg ZD4054 versus Placebo in Patients with Hormone-resistant Prostate Cancer and Bone Metastasis who are Pain Free or Mildly Symptomatic

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 M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases. •This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo. •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. •All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy. •Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour. •No patients will be deprived of standard prostate cancer therapy. Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Data Summary

All data from control arm

Study Objectives

Primary Objective: To determine the effect of ZD4054 on overall survival, defined as time to death (from randomisation) from any cause, compared to placebo

Outcome Measures

primary Outcome Variable; Overall survival defined as: Time to death (from randomisation) from any cause

Available Downloads:

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

PROTOCOL: Clinical Study Protocol redacted.pdf

CRF: Sample CRF Version 78 5.pdf

DATA DICTIONARY: De indentification RDB standards STUDY14.xlsx

DATA (COMPARATOR ARM): D4320C00014 De-Identified RDB Data.zip

Other: D4320C00014 Format XPT.zip

Other: D4320C00014 Formats.zip