Selumetinib in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

This study has been terminated.
(Closed Prematurely.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01278615
First received: January 15, 2011
Last updated: January 4, 2016
Last verified: July 2014
Results First Received: September 4, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Recurrent Adult Diffuse Large Cell Lymphoma
Interventions: Other: Laboratory Biomarker Analysis
Drug: Selumetinib

  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
No text entered.

Reporting Groups
  Description
Treatment (Selumetinib)

Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO


Participant Flow:   Overall Study
    Treatment (Selumetinib)  
STARTED     16  
COMPLETED     14  
NOT COMPLETED     2  
Withdrawal by Subject                 2  



  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
Treatment (Selumetinib)

Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO


Baseline Measures
    Treatment (Selumetinib)  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Median (Full Range)
  70  
  (28.7 to 86.0)  
Gender  
[units: participants]
 
Female     7  
Male     9  



  Outcome Measures
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1.  Primary:   Response Rate (Complete Response [CR] and Partial Response [PR]) in Patients Treated With Selumetinib   [ Time Frame: Up to 3 years ]

2.  Primary:   Disease Control Rate (Complete Response [CR], Partial Response [PR], and Stable Disease [SD]) in Patients Treated With Selumetinib   [ Time Frame: Up to 3 years ]

3.  Secondary:   Duration of Response   [ Time Frame: From the documented beginning of response (CR or PR) to the time of relapse, assessed up to 3 years ]

4.  Secondary:   Incidence of Adverse Events Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0   [ Time Frame: Up to 3 years ]

5.  Secondary:   Overall Survival   [ Time Frame: Date of study entry to the date of death, assessed up to 3 years ]

6.  Secondary:   Progression-free Survival   [ Time Frame: Time from entry onto study until lymphoma progression or death from any cause, assessed up to 3 years ]

7.  Secondary:   Time to Treatment Failure   [ Time Frame: Time from study entry to treatment failure, defined as lymphoma progression or withdrawal from treatment due to adverse events, assessed up to 3 years. Patients who die without progression while still on therapy will be censored as of the time of death. ]


  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: Dr. Sonali M. Smith
Organization: University of Chicago
phone: 773-834-2895
e-mail: smsmith@medicine.bsd.uchicago.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01278615     History of Changes
Other Study ID Numbers: NCI-2011-02558
NCI-2011-02558 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NU-10H03
CDR0000690641
12-0110 ( Other Identifier: University of Chicago Comprehensive Cancer Center )
8611 ( Other Identifier: CTEP )
N01CM00071 ( US NIH Grant/Contract Award Number )
N01CM62201 ( US NIH Grant/Contract Award Number )
P30CA014599 ( US NIH Grant/Contract Award Number )
Study First Received: January 15, 2011
Results First Received: September 4, 2015
Last Updated: January 4, 2016
Health Authority: United States: Food and Drug Administration