Pilot Study of be Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00706342
First received: June 25, 2008
Last updated: August 19, 2014
Last verified: August 2014
Results First Received: July 23, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Purpura, Thrombocytopenic, Idiopathic
Intervention: Drug: Fostamatinib Disodium / R935788

  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
R788 PO Tablet containing 75mg BID to 225mg BID R788.

Participant Flow:   Overall Study
    R788 PO  
STARTED     18  
COMPLETED     0  
NOT COMPLETED     18  
Adverse Event                 3  
Not responding to treatment                 2  
Withdrawn due to failure to respond                 1  
Death                 1  
Withdrew from the study on his own.                 1  
Investigator discretion                 2  
Non-responder Week 12                 1  
Ongoing                 6  
WIthdrawal of consent                 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.
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Reporting Groups
  Description
R788 PO Tablet containing 75mg BID to 225mg BID R788.

Baseline Measures
    R788 PO  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Mean ± Standard Deviation
  61.9  ± 15.63  
Age  
[units: years]
Median ( Full Range )
 
Median (Range)     65  
  ( 30 to 81 )  
Gender  
[units: Participants]
 
Female     10  
Male     8  



  Outcome Measures
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1.  Primary:   Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2   [ Time Frame: 2 weeks ]

2.  Primary:   Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 6   [ Time Frame: 6 Weeks ]

3.  Primary:   Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 12   [ Time Frame: 12 Weeks ]

4.  Primary:   Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 24   [ Time Frame: 24 Weeks ]

5.  Primary:   Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 12   [ Time Frame: 12 Months ]

6.  Primary:   Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 24   [ Time Frame: 24 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 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: Bernadette Weidman
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


Publications of Results:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00706342     History of Changes
Other Study ID Numbers: D4300C00022, C-935788-007
Study First Received: June 25, 2008
Results First Received: July 23, 2014
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration