Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01499303
First received: December 19, 2011
Last updated: August 8, 2014
Last verified: August 2014
Results First Received: June 17, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diffuse Large B-Cell Lymphoma
Intervention: Drug: Fostamatinib

  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
This study was conducted in the US and UK. Patient enrolment was completed on 14 June 2013. However three patients, considered by the Investigator to still be receiving clinical benefit, continue to receive fostamatinib. A total of 102 patients were enrolled and 68 received Fostamatinib doses of 100mg or 200mg and 38 Screen Failures.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
100mg BID 100mg Fostmatinib BID
200mg BID 200mg Fostmatinib BID

Participant Flow:   Overall Study
    100mg BID     200mg BID  
STARTED     21     47  
COMPLETED     18     40  
NOT COMPLETED     3     7  
Ongoing                 2                 1  
Withdrawal by Subject                 0                 1  
Adverse Event                 1                 4  
Unknown                 0                 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.
Most patients were male (69.1%). The mean age (± standard deviation) was 63.6 ± 12.6 years.

Reporting Groups
  Description
100mg BID 100mg Fostmatinib BID
200mg BID 200mg Fostmatinib BID
Total Total of all reporting groups

Baseline Measures
    100mg BID     200mg BID     Total  
Number of Participants  
[units: participants]
  21     47     68  
Age  
[units: years]
Mean ± Standard Deviation
  62.9  ± 12.38     63.9  ± 12.78     63.6  ± 12.57  
Gender  
[units: Participants]
     
Female     9     12     21  
Male     12     35     47  



  Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: Week 8 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Bernadette Weidman
Organization: AstraZeneca
phone: 800-456-3669
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01499303     History of Changes
Other Study ID Numbers: D4302C00001
Study First Received: December 19, 2011
Results First Received: June 17, 2014
Last Updated: August 8, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Federal Government
United States: Food and Drug Administration