Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-Resistant Prostate Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00744497

Purpose

The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib in addition to docetaxel and prednisone.

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: placebo + docetaxel/prednisone Drug: dasatinib + docetaxel/prednisone	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Docetaxel Dasatinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Double-Blind Phase III Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Overall survival [ Time Frame: from beginning to end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of change in urinary N-telopeptide values [ Time Frame: from beginning to end of study ] [ Designated as safety issue: No ]
Time to first skeletal related event [ Time Frame: from beginning to end of study ] [ Designated as safety issue: No ]
Rate of change in pain intensity [ Time Frame: from beginning to end of study ] [ Designated as safety issue: No ]
Time to prostate specific antigen (PSA) progression [ Time Frame: from beginning to end of study ] [ Designated as safety issue: No ]
Objective tumor response rate [ Time Frame: from beginning to end of study ] [ Designated as safety issue: No ]
Rate of stable disease by bone scan [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
Safety and tolerability of combination [ Time Frame: from beginning to end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1380
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: placebo + docetaxel/prednisone Tablets, Oral, 0 mg, Once daily, average 18 weeks, depending on response
2: Active Comparator	Drug: dasatinib + docetaxel/prednisone Tablets, Oral, 100 mg, Once daily, average 18 weeks, depending on response

Eligibility

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

Criteria

Inclusion Criteria:

Histologically diagnosed prostate cancer
Evidence of metastatic disease
Evidence of progression, by rising PSA, nodal/visceral disease, bone scan, or local recurrence
Serum testosterone ≤ 50 ng/dL
Must be able to take oral medications
Performance status 0 or 1

Exclusion Criteria:

Active brain or leptomeningeal metastases
Clinically significant cardiovascular disease
Pleural or pericardial effusion
Currently active second malignancy
Uncontrolled intercurrent illness
Prior cytotoxic chemotherapy, with the exception of estramustine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744497

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 182 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-227
Study First Received:	August 29, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00744497
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: National Committee of Ethics in Research; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Hungary: National Institute of Pharmacy; India: Drugs Controller General of India; Ireland: Irish Medicines Board; Italy: Ministry of Health; Korea: Food and Drug Administration; Mexico: Federal Commission for Sanitary Risks Protection; Norway: The National Committees for Research Ethics in Norway; Peru: Health National Institute; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Russia: FSI Scientific Center of Expertise of Medical Application; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Docetaxel
Prednisone
Prostatic Diseases
Genital Neoplasms, Male

Dasatinib
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors

Glucocorticoids
Hormones
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009