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Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-Resistant Prostate Cancer (READY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00744497
First received: August 29, 2008
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Assessed at each study visit (every 3 weeks while on treatment and every 12 weeks during follow-up) to death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare objective tumor response rate [by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria] for subjects with measurable disease at baseline [ Time Frame: Every 12 weeks until progression of disease ] [ Designated as safety issue: No ]
  • Compare time to first skeletal -related event [ Time Frame: Every 12 weeks until progression of disease ] [ Designated as safety issue: No ]
  • Compare proportion of subjects with reduction in urinary N-telopeptide from baseline [ Time Frame: Each study visit (every 3 weeks while on treatment and every 12 weeks during follow up) until progression of disease ] [ Designated as safety issue: No ]
  • Compare progression free survival [ Time Frame: Each study visit (every 3 weeks while on treatment and every 12 weeks during follow up) until progression of disease ] [ Designated as safety issue: No ]
  • Compare time to Prostate Specific Antigen (PSA) progression [ Time Frame: Each study visit (every 3 weeks while on treatment and every 12 weeks during follow up) until progression of disease ] [ Designated as safety issue: No ]
  • Compare proportion of subjects with reduction in pain intensity from baseline [ Time Frame: Each study visit (every 3 weeks while on treatment and every 12 weeks during follow up) until progression of disease ] [ Designated as safety issue: No ]
  • Evaluate safety and tolerability of combination Dasatinib/Docetaxel by collection of adverse event information and review of laboratory values at every study visit [ Time Frame: Continuously throughout study (on treatment every 3 weeks and during follow up every 12 weeks) to death ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: October 2008
Estimated Study Completion Date: February 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo + Docetaxel/Prednisone
Tablets, Oral, 0 mg, Once daily, average 18 weeks, depending on response
Active Comparator: 2 Drug: Dasatinib + Docetaxel/Prednisone
Tablets, Oral, 100 mg, Once daily, average 18 weeks, depending on response
Other Names:
  • Sprycel
  • BMS-354825

  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, 1 or 2

Exclusion Criteria:

  • Symptomatic 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

  Show 198 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  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

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00744497     History of Changes
Other Study ID Numbers: CA180-227, 2008-000701-11
Study First Received: August 29, 2008
Last Updated: October 5, 2012
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: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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:National Committee for Medical and Health Research Ethics
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

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Dasatinib
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013