A Phase III Trial of ZD4054 (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00626548

Purpose

Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 in hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.

ZD4054 is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.

All patients participating in this clinical trial will receive existing 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 Drug: Luteinising hormone-releasing hormone analogue (LHRHa) Drug: Megace Drug: Estradiol Drug: Prednisolone Drug: Ketoconazole Drug: Docetaxel	Phase III

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, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisolone Estradiol Estradiol 3-benzoate Prednisolone acetate Depo-medrol Polyestradiol phosphate Depogen Ketoconazole Medrol veriderm Fungarest Methylprednisolone Estradiol dipropionate Docetaxel ZD4054 Prednisolone sodium phosphate Estradiol cypionate Estradiol valerate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate Estradiol acetate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Progression-free survival and Overall survival [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerability and safety profile of ZD4054 [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
Health Related Quality of Life [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
Time to prostate-specific antigen (PSA) progression [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
Time to symptomatic progression [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	January 2008
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Existing Prostate Cancer Treatment	Drug: Luteinising hormone-releasing hormone analogue (LHRHa) Standard acceptable dose Drug: Megace Standard medical dose Drug: Estradiol Standard medically acceptable dose Drug: Prednisolone Standard medically acceptable dose Drug: Ketoconazole Standard medically acceptable dose Drug: Docetaxel Standard medically acceptable dose
2: Experimental ZD4054 + Existing Prostate Cancer Therapy	Drug: ZD4054 10 mg once daily oral dose Drug: Luteinising hormone-releasing hormone analogue (LHRHa) Standard acceptable dose Drug: Megace Standard medical dose Drug: Estradiol Standard medically acceptable dose Drug: Prednisolone Standard medically acceptable dose Drug: Ketoconazole Standard medically acceptable dose Drug: Docetaxel Standard medically acceptable 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 study.

Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases)
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 may NOT be eligible to participate in this study.

Currently using opiates based pain killers) for cancer related pain
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: NCT00626548

Contacts

Contact: AstraZeneca Cancer Study Locator Service, (US and CA only)	877-400-4656	astrazeneca@emergingmed.com
Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com

Show 344 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Kurt Miller, Prof., M.D.	Charité Campus Benjamin Franklin
Principal Investigator:	Tia Higano, MD	University of Washington

More Information

Additional Information:

Cancer Study Locator (US and Canada only) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AstraZeneca ( Thomas Morris, BSc, MB BCh, MRCP, FFPM, ZD4054 Medical Science Director )
Study ID Numbers:	D4320C00015
Study First Received:	January 24, 2008
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00626548 History of Changes
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

Additional relevant MeSH terms:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Neoplasms
Neoplasms
Anti-Inflammatory Agents
Anti-Infective Agents
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Genital Diseases, Male
Ketoconazole
Glucocorticoids
Hormones
Pharmacologic Actions
Estradiol
Docetaxel
Therapeutic Uses
Antifungal Agents
Prednisolone

ClinicalTrials.gov processed this record on February 08, 2010