A Phase III Trial of ZD4054 (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00554229

Purpose

Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 in patients with hormone resistant prostate cancer and bone metastases.

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 can improve survival compared with placebo.
ZD4054 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 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, 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.

Condition	Intervention	Phase
Prostate Cancer	Drug: ZD4054 Other: Best supportive care	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Trial to Test the Efficacy of ZD4054, an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Overall survival [ Time Frame: study visits and assessments every 4 weeks for first 12 weeks then every 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: study visits and assessments every 4 weeks for first 12 weeks then every 12 weeks ] [ Designated as safety issue: No ]
Tolerability and safety profile of ZD4054 [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]
Time to use of opiates [ Time Frame: Assessed every 12 weeks after progression ] [ Designated as safety issue: No ]
Incidence of skeletal related events [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]
Bone metastases formation [ Time Frame: Assessed every 12 weeks after progression ] [ Designated as safety issue: No ]
Health Related Quality of Life [ Time Frame: Assessed every visit ] [ Designated as safety issue: No ]
Time to prostate-specific antigen (PSA) progression [ Time Frame: Assessed every 12 weeks after progression ] [ Designated as safety issue: No ]
Time to pain progression [ Time Frame: Assessed every 12 weeks after progression ] [ Designated as safety issue: No ]
Time to initiation of chemotherapy [ Time Frame: Assessed every 12 weeks after progression ] [ Designated as safety issue: No ]
Pharmacokinetic characteristics of ZD4054 [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	580
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ZD4054 + best supportive care	Drug: ZD4054 10 mg oral tablet ZD4054 + best supportive care
2: Placebo Comparator Best Supportive Care	Other: Best supportive care various established treatments for prostate cancer

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who answer TRUE to the following criteria may be eligible to participate in this trial.

Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)
Increasing Prostate Specific Antigen (PSA) over a one month period
No pain, or mild pain from prostate cancer
Currently receiving treatment with surgical or medical castration

Exclusion Criteria:

Patients who answer TRUE to the following may NOT eligible to participate in this trial.

Currently using opiates based pain killers)
Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
Suffering from heart failure or had a myocardial infarction within last 6 months
A history of epilepsy or seizures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554229

Contacts

Contact: ZD4054 ENTHUSE M1 Study Information

+49-6103-9040

zd4054@iconirl.com

Show 201 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Martin Gleave, MD, FRCSC, FACS	The Prostate Centre at Vancouver General Hospital
Principal Investigator:	Joel B Nelson, MD	University of Pittsburgh

More Information

Responsible Party:	AstraZeneca ( Thomas Morris, BSc, MB BCh, MRCP, FFPM, ZD4054 Medical Science Director )
Study ID Numbers:	D4320C00014, EUDRACT No 2007-003227-20
Study First Received:	November 2, 2007
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00554229
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Hormone Resistant Prostate Cancer
Endothelin A Receptor Antagonist
Endothelin A
Endothelin A antagonist

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis
Urogenital Neoplasms

Pain
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009