Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00131937
First received: August 16, 2005
Last updated: August 5, 2015
Last verified: July 2015
Results First Received: June 10, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Hepatosplenic T-cell Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Intervention: Drug: sorafenib tosylate

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Treatment (Sorafenib)

Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate: Given orally


Participant Flow:   Overall Study
    Treatment (Sorafenib)  
STARTED     14  
COMPLETED     0  
NOT COMPLETED     14  
Adverse Event                 3  
Withdrawal by Subject                 2  
Physician Decision                 1  
Disease Progression                 7  
Alternative therapy                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Treatment (Sorafenib)

Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate: Given orally


Baseline Measures
    Treatment (Sorafenib)  
Number of Participants  
[units: participants]
  14  
Age  
[units: years]
Median (Full Range)
  69.5  
  (38 to 88)  
Gender  
[units: participants]
 
Female     5  
Male     9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response (OR) Rate   [ Time Frame: Assessed at the end of Cycle 2 and Cycle 6 (1 cycle = 28 days). Then every 3 months beginning Cycle 9 if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years. ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years ]

3.  Secondary:   Overall Survival   [ Time Frame: Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
The study did not meet pre-specified criteria for continuing to second stage accrual (at least one response among the first 12 eligible patients), and was therefore closed per protocol without full accrual.


  More Information
  Hide More Information

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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00131937     History of Changes
Other Study ID Numbers: NCI-2014-00658
E1404 ( Other Identifier: Eastern Cooperative Oncology Group )
U10CA021115 ( US NIH Grant/Contract Award Number )
Study First Received: August 16, 2005
Results First Received: June 10, 2015
Last Updated: August 5, 2015
Health Authority: United States: Food and Drug Administration