Selumetinib in Cancers With BRAF Mutations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00888134
First received: April 23, 2009
Last updated: December 10, 2015
Last verified: July 2015
Results First Received: December 10, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Adult Solid Neoplasm
Intervention: 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
Participants 'complete' the treatment period if they ended their treatment for disease progression, unacceptable toxicity, withdrawal of consent, or intercurrent illness. Those participants who completed treatment then enter a follow-up period when they are followed until death or lost-to-follow-up.

Reporting Groups
  Description
Treatment (Selumetinib)

Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO


Participant Flow for 2 periods

Period 1:   Treatment With Study Drug
    Treatment (Selumetinib)  
STARTED     28  
COMPLETED     27 [1]
NOT COMPLETED     1  
Withdrawal by Subject                 1  
[1] 21 had progressive disease; 5 had unacceptable toxicity; 1 finished treatment

Period 2:   Follow-up
    Treatment (Selumetinib)  
STARTED     27  
COMPLETED     26 [1]
NOT COMPLETED     1  
being followed for long-term survival                 1  
[1] 23 died; 3 were lost-to-follow-up



  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
Treatment (Selumetinib)

Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks 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]
  28  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     19  
>=65 years     9  
Gender  
[units: participants]
 
Female     17  
Male     11  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     27  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     27  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     28  
Type of cancer  
[units: participants]
 
Non small-cell lung cancer     14  
Colon cancer     10  
Other cancer     4  



  Outcome Measures
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1.  Primary:   Objective Response Rate in Patients With Cancers Other Than Melanoma   [ Time Frame: 4 years ]

2.  Secondary:   AKT Pathway Activity   [ Time Frame: Up to 4 years ]

3.  Secondary:   Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers   [ Time Frame: Up to 4 years ]

4.  Secondary:   Progression-free Survival   [ Time Frame: 4 months ]

5.  Secondary:   Sensitivity and Specificity of Detection of the BRAF V600E Mutation in CTC Using the CTC-chip   [ Time Frame: Up to 4 years ]


  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: Donald P. Lawrence
Organization: Massachusetts General Hospital
phone: 617-643-3614
e-mail: dplawrence@mgh.harvard.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00888134     History of Changes
Other Study ID Numbers: NCI-2013-00576
NCI-2013-00576 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA006516 ( US NIH Grant/Contract Award Number )
U01CA062490 ( US NIH Grant/Contract Award Number )
CDR642346
N01CM62206 ( US NIH Grant/Contract Award Number )
09-005 ( Other Identifier: Massachusetts General Hospital Cancer Center )
8281 ( Other Identifier: CTEP )
Study First Received: April 23, 2009
Results First Received: December 10, 2015
Last Updated: December 10, 2015
Health Authority: United States: Food and Drug Administration