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Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00446095
First received: March 8, 2007
Last updated: August 9, 2016
Last verified: August 2016
Results First Received: May 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: 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
A total of 81 patients with lymphoid malignancy were enrolled from 22 March 2007 until 31 January 2008, of which 13 were in Phase I and 68 in Phase II. This study was conducted by 11 investigators at 11 sites in U.S. Primary efficacy analysis was based on Phase II patients so only results from Phase II are posted.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was screening period of up to 21 days, after which if all inclusion/exclusion criteria were met, patients were dosed with fostamatinib treatment for a treatment period of 8 weeks. Patients could then continue treatment until disease progression, toxicity or withdrawal from the study

Reporting Groups
  Description
Phase II: DLBCL Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase I: 200mg R788 BID Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
Phase I: 250mg R788 BID Patients who received 250mg R788 orally twice daily (PO BID) in Phase I

Participant Flow for 2 periods

Period 1:   Phase II (8 Weeks)
    Phase II: DLBCL     Phase II: 250mg R788 BID     Phase II: Other Lymphomas     Phase I: 200mg R788 BID     Phase I: 250mg R788 BID  
STARTED     23     21     24     0     0  
COMPLETED     11     18     21     0     0  
NOT COMPLETED     12     3     3     0     0  
Lost to Follow-up                 1                 0                 0                 0                 0  
Adverse Event                 0                 1                 1                 0                 0  
Withdrawal by Subject                 1                 0                 0                 0                 0  
Physician Decision                 1                 0                 0                 0                 0  
Lack of Efficacy                 9                 2                 1                 0                 0  
Ongoing                 0                 0                 1                 0                 0  

Period 2:   Phase I (28 Days)
    Phase II: DLBCL     Phase II: 250mg R788 BID     Phase II: Other Lymphomas     Phase I: 200mg R788 BID     Phase I: 250mg R788 BID  
STARTED     0     0     0     6     7  
COMPLETED     0     0     0     5     4  
NOT COMPLETED     0     0     0     1     3  
Adverse Event                 0                 0                 0                 1                 0  
Lack of Efficacy                 0                 0                 0                 0                 3  



  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.
No text entered.

Reporting Groups
  Description
Phase II: DLBCL Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase I: 200mg R788 BID Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
Phase I: 250mg R788 BID Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
Total Total of all reporting groups

Baseline Measures
    Phase II: DLBCL     Phase II: 250mg R788 BID     Phase II: Other Lymphomas     Phase I: 200mg R788 BID     Phase I: 250mg R788 BID     Total  
Number of Participants  
[units: participants]
  23     21     24     6     7     81  
Age  
[units: Years]
Mean (Full Range)
  63.0  
  (41 to 87)  
  59.0  
  (41 to 74)  
  62.0  
  (51 to 77)  
  78.5  
  (70 to 91)  
  61  
  (52 to 80)  
  61.5  
  (41 to 87)  
Gender  
[units: Participants]
           
Female     5     8     7     4     5     29  
Male     18     13     17     2     2     52  
Race/Ethnicity, Customized  
[units: Participants]
           
Caucasian     20     19     21     6     5     71  
Black/African American     2     0     3     0     1     6  
Asian     0     2     0     0     1     3  
Other: Russian     1     0     0     0     0     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate as Assessed According to the“Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).   [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) ]

2.  Primary:   Clinical Benefit Rate as Assessed According to the “Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).   [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Overall survival is measured from the time of first administration of study drug to death. (Maximum duration of treatment 511days, Maximum duration of follow-up 812 Days) ]


  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
This is a small, non-randomized study. Comparisons between the 3 groups cannot be reliably made and should be interpreted with caution.


  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: Anne-Marie Duliege, MD
Organization: Rigel
phone: 650-624-1100
e-mail: clinicaltrials@rigel.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00446095     History of Changes
Other Study ID Numbers: D4300C00023
C-935788-009 ( Other Identifier: Rigel Pharmaceuticals )
Study First Received: March 8, 2007
Results First Received: May 14, 2014
Last Updated: August 9, 2016
Health Authority: United States: Food and Drug Administration