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


Tracking Information

Start Date  ICMJEOctober 2008
Estimated Primary Completion DateDecember 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)		Overall survival [ Time Frame: from beginning to end of study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: August 29, 2008)		Overall survival [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00744497 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: October 16, 2009)
  • 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 ]
  • Safety and tolerability of combination [ Time Frame: from beginning to end of study ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJE 
 (submitted: August 29, 2008)
  • Rate of change in urinary N-telopeptide values [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Time to first skeletal related event [ Time Frame: upon occurrence ] [ Designated as safety issue: No ]
  • Rate of change in pain intensity [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]
  • Time to PSA progression [ Time Frame: upon occurrence ] [ Designated as safety issue: No ]
  • Objective tumor response rate [ Time Frame: throughout the 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: throughout the study ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title  ICMJERandomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-Resistant Prostate Cancer
Official Title  ICMJEA Randomized Double-Blind Phase III Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEProstatic Neoplasms
Intervention  ICMJE
  • Drug: placebo + docetaxel/prednisone
    Tablets, Oral, 0 mg, Once daily, average 18 weeks, depending on response
  • Drug: dasatinib + docetaxel/prednisone
    Tablets, Oral, 100 mg, Once daily, average 18 weeks, depending on response
    Other Names:
    • Sprycel
    • BMS-354825
Study Arms / Comparison Groups
  • 1: Placebo Comparator
    Intervention: Drug: placebo + docetaxel/prednisone
  • 2: Active Comparator
    Intervention: Drug: dasatinib + docetaxel/prednisone

Recruitment Information

Estimated Enrollment  ICMJE1380
Estimated Completion DateDecember 2012
Estimated Primary Completion DateDecember 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderMale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
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.
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Ireland,   Italy,   Korea, Republic of,   Mexico,   Norway,   Peru,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00744497
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECA180-227
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb