A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

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

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 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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

7.  Secondary:

Overall Survival for Participants Who Had a BRAF V600E Mutation   [ Time Frame: Up to 60 months ]

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) ]

9.  Secondary:

Number of Participants With AEs and Serious Adverse Events (SAEs)   [ Time Frame: Up to 60 months ]

10.  Secondary:

Number of Participants With Change From Baseline in Clinical Chemistry and Hematology Toxicity Grades   [ Time Frame: Up to 60 months ]

11.  Secondary:

Number of Participants With Change From Baseline in Temperature and Pulse Rate   [ Time Frame: Up to 60 months ]

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 ]

13.  Secondary:

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

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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