A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01153763 |
Recruitment Status :
Completed
First Posted : June 30, 2010
Results First Posted : June 2, 2014
Last Update Posted : September 27, 2017
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Melanoma |
Intervention |
Drug: GSK2118436 |
Enrollment | 92 |
Participant Flow
Recruitment Details | 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 | 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. |
Arm/Group Title | GSK2118436 150 mg |
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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. |
Period Title: Overall Study | |
Started | 92 |
Completed | 71 |
Not Completed | 21 |
Reason Not Completed | |
Study Closed | 16 |
Lost to Follow-up | 1 |
Physician Decision | 2 |
Withdrawal by Subject | 2 |
Baseline Characteristics
Arm/Group Title | GSK2118436 150 mg | |
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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. | |
Overall Number of Baseline Participants | 92 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 92 participants | |
54.8 (14.44) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 92 participants | |
Female |
43 46.7%
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Male |
49 53.3%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 92 participants |
White | 91 | |
American Indian or Alaska Native | 1 |
Outcome Measures
Adverse Events
Limitations and Caveats
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
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01153763 |
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 |