Saracatinib in Treating Patients With Prostate Cancer

This study has been terminated.
(Per protocol, study was terminated due to low rate of randomized patients.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01267266
First received: December 24, 2010
Last updated: March 18, 2015
Last verified: January 2013
Results First Received: January 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Interventions: Drug: saracatinib
Other: hydrocortisone/placebo

  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
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Reporting Groups
  Description
Arm I (Saracatinib) Patients receive 175 mg oral saracatinib once daily on days 1-28.
Arm II (Placebo) Patients receive oral placebo once daily on days 1-28.

Participant Flow for 3 periods

Period 1:   Enrollment Phase
    Arm I (Saracatinib)     Arm II (Placebo)  
STARTED     33     0  
COMPLETED     31 [1]   0  
NOT COMPLETED     2     0  
Withdrawal by Subject                 2                 0  
[1] Two patients signed consent but did not proceed to treatment.

Period 2:   Lead-in Phase
    Arm I (Saracatinib)     Arm II (Placebo)  
STARTED     31     0  
COMPLETED     8 [1]   0  
NOT COMPLETED     23     0  
Lack of Efficacy                 20                 0  
Adverse Event                 2                 0  
Withdrawal by Subject                 1                 0  
[1] 12 patients had radiographic progression, 8 clinical progression, 2 toxicity, 1 withdrawal.

Period 3:   Randomized Phase
    Arm I (Saracatinib)     Arm II (Placebo)  
STARTED     3 [1]   5 [2]
COMPLETED     3     5  
NOT COMPLETED     0     0  
[1] 3 of 8 patients randomized to saracatinib.
[2] 5 of 8 patients randomized to placebo.



  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.
Patients entering lead-in phase.

Reporting Groups
  Description
Arm I (Saracatinib) Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Arm I (Saracatinib)  
Number of Participants  
[units: participants]
  31  
Age  
[units: years]
Median (Full Range)
  71    (48 to 87)  
Gender  
[units: participants]
 
Female     0  
Male     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.)   [ Time Frame: Up to 6 months. ]

2.  Secondary:   Toxicity and Incidence of Adverse Events   [ Time Frame: Up to 6 months. ]

3.  Secondary:   Toxicity and Incidence of Adverse Events.   [ Time Frame: Up to 6 months. ]

4.  Secondary:   Correlation of Molecular Profile With Clinical Outcomes   [ Time Frame: Up to 2 years ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Walter M. Stadler
Organization: University of Chicago
phone: 773-702-4150
e-mail: wstadler@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01267266     History of Changes
Other Study ID Numbers: NCI-2011-02563, NCI-2011-02563, CDR0000691725, 10-436-B, 8446, N01CM00099, N01CM00071, U01CA062491, P30CA014599
Study First Received: December 24, 2010
Results First Received: January 30, 2015
Last Updated: March 18, 2015
Health Authority: United States: Food and Drug Administration