A Phase III Trial of ZD4054 (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00617669

Purpose

Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 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 can further improve survival compared with docetaxel alone.

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 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, 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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Docetaxel Drug: ZD4054	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Overall survival [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
Tolerability and safety profile of ZD4054 [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
Incidence of skeletal related events [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
Time to prostate-specific antigen (PSA) progression [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
Time to pain progression [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
Pain response [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
Health Related Quality of Life [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
PSA response [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1044
Study Start Date:	January 2008
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator docetaxel monotherapy	Drug: Docetaxel intravenous infusion given every three weeks
2: Experimental docetaxel + ZD4054	Drug: Docetaxel intravenous infusion given every three weeks Drug: ZD4054 10 mg oral once daily dose

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 metastasis)
Increasing Prostate Specific Antigen (PSA) over a one month period
Currently receiving treatment with surgical or medical castration

Exclusion Criteria:

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

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: NCT00617669

Contacts

Contact: ZD4054 ENTHUSE M1C Study Information, outside US and Canada	+49-6103-9040	zd4054@iconirl.com
Contact: AstraZeneca Cancer Study Locator Service	877-400-4656	astrazeneca@emergingmed.com

Show 167 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Karim Fizazi, MD, PhD	Institut Gustave Roussy
Principal Investigator:	Judd W Moul, MD, FACS	Duke University

More Information

US and Canada only This link exits the ClinicalTrials.gov site

Responsible Party:	AstraZeneca ( Thomas Morris, BSc, MB BCh, MRCP, FFPM, ZD4054 Medical Science Director )
Study ID Numbers:	D4320C00033
Study First Received:	January 24, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00617669
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:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009