Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00439270
First received: February 22, 2007
Last updated: February 28, 2014
Last verified: February 2014
Results First Received: June 25, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Prostate Cancer
Interventions: Drug: Dasatinib
Drug: Docetaxel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 49 participants were enrolled in the study, and 46 entered the treatment period and received at least 1 dose of dasatinib.

Reporting Groups
  Description
Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.

Participant Flow for 2 periods

Period 1:   Phase 1 (18.1 Months)
    Dasatinib, 50 mg + Docetaxel, 60 mg/m^2     Dasatinib, 50 mg + Docetaxel, 75 mg/m^2     Dasatinib, 70 mg + Docetaxel, 75 mg/m^2     Dasatinib, 100 mg + Docetaxel, 75 mg/m^2     Dasatinib, 120 mg + Docetaxel, 75 mg/m^2  
STARTED     3 [1]   3 [1]   3 [1]   4 [1]   3 [1]
COMPLETED     0 [2]   0 [2]   0 [2]   4 [2]   0 [2]
NOT COMPLETED     3     3     3     0     3  
Disease progression                 3                 2                 3                 0                 3  
Study drug toxicity                 0                 1                 0                 0                 0  
[1] Participants who received treatment
[2] Remained on study

Period 2:   Phase 2 (51.6 Months)
    Dasatinib, 50 mg + Docetaxel, 60 mg/m^2     Dasatinib, 50 mg + Docetaxel, 75 mg/m^2     Dasatinib, 70 mg + Docetaxel, 75 mg/m^2     Dasatinib, 100 mg + Docetaxel, 75 mg/m^2     Dasatinib, 120 mg + Docetaxel, 75 mg/m^2  
STARTED     0     0     0     34 [1]   0  
COMPLETED     0     0     0     0     0  
NOT COMPLETED     0     0     0     34     0  
Disease progression                 0                 0                 0                 18                 0  
Poor compliance/noncompliance                 0                 0                 0                 1                 0  
Study drug toxicity                 0                 0                 0                 6                 0  
Maximum clinical benefit                 0                 0                 0                 3                 0  
No longer meets study criteria                 0                 0                 0                 1                 0  
Withdrawal by Subject                 0                 0                 0                 2                 0  
Adverse event unrelated to study drug                 0                 0                 0                 2                 0  
Insurance no longer covered patient care                 0                 0                 0                 1                 0  
[1] Includes 4 patients who completed Phase 1



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who received at least 1 dose of dasatinib

Reporting Groups
  Description
Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Total Total of all reporting groups

Baseline Measures
    Dasatinib, 50 mg + Docetaxel, 60 mg/m^2     Dasatinib, 50 mg + Docetaxel, 75 mg/m^2     Dasatinib, 70 mg + Docetaxel, 75 mg/m^2     Dasatinib, 100 mg + Docetaxel, 75 mg/m^2     Dasatinib, 120 mg + Docetaxel, 75 mg/m^2     Total  
Number of Participants  
[units: participants]
  3     3     3     34     3     46  
Age, Customized  
[units: Participants]
           
<65 years     0     1     1     19     2     23  
>=65 years     3     2     2     15     1     23  
Gender  
[units: Participants]
           
Female     0     0     0     0     0     0  
Male     3     3     3     34     3     46  
Race/Ethnicity, Customized  
[units: Participants]
           
Black or African American     0     0     0     4     0     4  
White     3     3     3     29     3     41  
Other     0     0     0     1     0     1  
Race/Ethnicity, Customized  
[units: Participants]
           
Hispanic/Latino     0     0     0     1     0     1  
Not Hispanic/Latino     3     3     3     33     3     45  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD) of Dasatinib Administered With Docetaxel   [ Time Frame: From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42) ]

2.  Primary:   Recommended Phase 2 Dose of Dasatinib Administered With Docetaxel, 75 mg/m^2   [ Time Frame: From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42) ]

3.  Secondary:   Percentage of Participants With a Prostate Specific Antigen (PSA) Response   [ Time Frame: At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment (up to 51.6 months) ]

4.  Secondary:   Duration of Prostate Specific Antigen (PSA) Response   [ Time Frame: At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment ]

5.  Secondary:   Number of Months of Progression-free Survival (PFS)   [ Time Frame: Patients with an event: time from first dose to disease progression or death, whichever occurs first. Patients without an event: time to last on-study PSA measurement, tumor assessment, or radionuclide bone scan assessment, whichever occurs last ]

6.  Secondary:   Percentage of Participants With an Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Pretreatment visit then every 6 weeks thereafter (up to 51.6 months) ]

7.  Secondary:   Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Pretreatment visit then every 6 weeks thereafter (up to 51.6 months) ]

8.  Secondary:   Number of Participants by Best On-study Bone Scan Assessment From Baseline   [ Time Frame: From Day 1 of therapy to last bone scan assessment (up to 51.6 months) ]

9.  Secondary:   Percentage of Participants With Improvement on Bone Scan   [ Time Frame: From Day 1 of therapy to last bone scan assessment (up to 51.6 months) ]

10.  Secondary:   Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6   [ Time Frame: At pretreatment visit and on Day 1 of Cycles 2 through 6, then Day 1 of every other cycle, at end of treatment, and at follow-up visit ]

11.  Secondary:   Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population   [ Time Frame: From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months) ]

12.  Secondary:   Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort   [ Time Frame: From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months) ]

13.  Secondary:   Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel   [ Time Frame: Cycle 1, Day 14 at 0, 0.5 , 1, 2, 3, 4, 7, 10, and 24 hours postdose ]

14.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel   [ Time Frame: Docetaxel: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose; dasatanib: Cycle 1, Day 14 at 0, .5, 1, 2, 3, 4, 7, 10, and 24 hours postdose ]

15.  Secondary:   Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity (AUC[Inf]) of Docetaxel   [ Time Frame: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose ]

16.  Secondary:   Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests   [ Time Frame: From Day 2 of Cycle 1 to up to 30 days after last dose of study drug (up to approximately 49 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00439270     History of Changes
Other Study ID Numbers: CA180-086
Study First Received: February 22, 2007
Results First Received: June 25, 2013
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration