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
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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

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
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: 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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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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