Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Back to the List
Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
May 2011
NCT00617669Uploaded 08-04-2014
Available for Download
PDS UID: Prostat_AstraZe_2008_104
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
PDS UID: Prostat_Multipl_2008_420Go to Study
Enhancing the Analytic Capacity of Prostat_AstraZe_2008_104 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionPrimary 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
SponsorAstraZeneca
Data ProviderAstraZeneca
Partial set or SubsetOriginal Data
Patients in dataset1494
# of Patients Control528
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/t7ms-z196
CDISC StandardAZ RDB analysis data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryEnthuse 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.
ConditionsProstate Cancer
Intervention TypeDrug: Docetaxel
Drug: ZD4054
Drug: Placebo
Drug(s)Drug: Docetaxel
Drug: Placebo
Drug: ZD4054
Total Enrolled1494
RandomizationRandomized
Blinding MethodTriple
Arms InterventionPlacebo + Docetaxel - Active Comparator
ZD4054 + Docetaxel - Experimental
Secondary IDN/A
PubMed (PMID)23569308
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Brazil
Canada
Czech Republic
Finland
France
Germany
Hungary
India
Italy
Korea, Republic of
Netherlands
Peru
Poland
Portugal
Romania
Russian Federation
Serbia
South Africa
Spain
Sweden
Switzerland
Taiwan
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLZibotentan CSP D4320C00033 With Redactions_Redacted.pdf
CRFNot Provided
DATA DICTIONARYRDB Standards - D4320C00015 and D4320C00033.xlsx
DATA (COMPARATOR ARM)D4320C00033 De-Identified RDB Data.zip
© 2024 Project Data Sphere
All rights reserved
Privacy PolicyTerms of Use