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A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01153763
First received: May 27, 2010
Last updated: November 19, 2015
Last verified: April 2015
History of Changes
Results First Received: June 12, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Drug: GSK2118436

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
GSK2118436 150 mg Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.

Participant Flow:   Overall Study
    GSK2118436 150 mg  
STARTED     92  
Ongoing (In Follow-up)     24  
COMPLETED     33  
NOT COMPLETED     59  
Lost to Follow-up                 2  
Physician Decision                 2  
Withdrawal by Subject                 2  
Death                 29  
Ongoing (In follow-up)                 24  



  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
GSK2118436 150 mg Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.

Baseline Measures
    GSK2118436 150 mg  
Number of Participants  
[units: participants]
 		  92  
Age  
[units: Years]
Mean (Standard Deviation) 		  54.8  (14.44)  
Gender  
[units: Participants]
 		 
Female     43  
Male     49  
Race/Ethnicity, Customized  
[units: participants]
 		 
White     91  
American Indian or Alaska Native     1  



  Outcome Measures
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1.  Primary:   Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator for Participants Who Had a BRAF V600E Mutation   [ Time Frame: From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to 26.9 weeks) ]
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2.  Secondary:   Number of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation   [ Time Frame: From the first dose of study medication until the first documented evidence of a confirmed complete response or partial response (up to 11 weeks) ]
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3.  Secondary:   Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation   [ Time Frame: From the first dose of study medication to the earliest date of disease progression or death due to any cause (up to 9.9 months) ]
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4.  Secondary:   Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation   [ Time Frame: From the first dose of study medication to the earliest date of disease progression or death due to any cause (up to 9.9 months) ]
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5.  Secondary:   Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation   [ Time Frame: From the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 31.3 weeks) ]
  Show Outcome Measure 5

6.  Secondary:   Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation   [ Time Frame: From the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 29.6 weeks) ]
  Show Outcome Measure 6

7.  Secondary:   Overall Survival for Participants Who Had a BRAF V600E Mutation   [ Time Frame: From the first dose of study medication to death due to any cause (up to 9.9 months) ]
  Show Outcome Measure 7

8.  Secondary:   Overall Survival for Participants Who Had a BRAF V600K Mutation   [ Time Frame: From the first dose to death due to any cause (up to 9.9 months) ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:

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


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01153763     History of Changes
Other Study ID Numbers: 113710
Study First Received: May 27, 2010
Results First Received: June 12, 2013
Last Updated: November 19, 2015
Health Authority: Italy: Agenzia Italiana del Farmaco
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
France: Agence Française de Sécurité Sanitaire des Produits de Santé
United States: Food and Drug Administration
Australia: Therapeutic Goods Administration