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A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01153763
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : June 2, 2014
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Drug: GSK2118436

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible participants received Dabrafenib (GSK2118436) 150 milligram (mg) twice daily and continued on treatment until disease progression, death, unacceptable adverse event (AE), or early termination of the study. The total duration of the study including a long-term follow-up phase was 5 years.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 211 participants with histologically confirmed BRAF mutation positive metastatic melanoma (Stage IV) were screened for eligibility. 152 participants had a BRAF V600E or V600K mutation and 92 participants with positive mutation were included in the study.

Reporting Groups
  Description
GSK2118436 150 mg Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . 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 
COMPLETED   71 
NOT COMPLETED   21 
Study Closed                16 
Lost to Follow-up                1 
Physician Decision                2 
Withdrawal by Subject                2 



  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
GSK2118436 150 mg Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . 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 
Overall Participants Analyzed 
[Units: Participants]
 		 92 
Age 
[Units: Years]
Mean (Standard Deviation) 		 54.8  (14.44) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      43  46.7% 
Male      49  53.3% 
Race/Ethnicity, Customized 
[Units: Participants]
 		 
White   91 
American Indian or Alaska Native   1 


  Outcome Measures

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: Up to 60 months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With a Best Overall Response of CR or PR as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation   [ Time Frame: Up to 60 months ]
  Show Outcome Measure 2

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: Up to 60 months ]
  Show Outcome Measure 3

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: Up to 60 months ]
  Show Outcome Measure 4

5.  Secondary:   Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation   [ Time Frame: Up to 60 months ]
  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: Up to 60 months ]
  Show Outcome Measure 6

7.  Secondary:   Overall Survival for Participants Who Had a BRAF V600E Mutation   [ Time Frame: Up to 60 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 60 months) ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants With AEs and Serious Adverse Events (SAEs)   [ Time Frame: Up to 60 months ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants With Change From Baseline in Clinical Chemistry and Hematology Toxicity Grades   [ Time Frame: Up to 60 months ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants With Change From Baseline in Temperature and Pulse Rate   [ Time Frame: Up to 60 months ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants With Increase From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Up to 60 months ]
  Show Outcome Measure 12

13.  Secondary:   Number of Participants With Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Levels   [ Time Frame: Up to 60 months ]
  Show Outcome Measure 13


  Serious Adverse Events


  Other Adverse Events


  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
This study met the criteria for completed. Participants who were still receiving study treatment at the time the study was closed were given the option to transfer to a rollover protocol.


  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 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
First Submitted: May 27, 2010
First Posted: June 30, 2010
Results First Submitted: June 12, 2013
Results First Posted: June 2, 2014
Last Update Posted: September 27, 2017