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A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

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
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Intervention Drug: GSK2118436
Enrollment 92
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
Hide Arm/Group Description 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
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants
54.8  (14.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
43
  46.7%
Male
49
  53.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 92 participants
White 91
American Indian or Alaska Native 1
1.Primary Outcome
Title 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
Hide Description A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis.) or PR (at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment was required at Week 12 if an initial response was seen at the Week 6 scan. Initial responses (CR/PR) that occured at Week 12 or later were required to be confirmed not less than 4 weeks and not more than 6 weeks after the criteria for response were first met. The analysis was performed on Primary efficacy Population which comprised of all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600E mutation.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Primary efficacy Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 76
Measure Type: Number
Unit of Measure: Participants
CR 5
PR 40
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2118436 150 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 59
Confidence Interval (2-Sided) 95%
48.2 to 70.3
Estimation Comments The estimated value represents the percentage of participants with a confirmed CR or a confirmed PR.
2.Secondary Outcome
Title 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
Hide Description A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment had to have been performed at Week 12 if an initial response was seen at the Week 6 scan. Initial responses (CR/PR) that occured at Week 12 or later should have been confirmed not less than 4 weeks and not more than 6 weeks after the criteria for response were first met. The analysis was performed on Secondary efficacy analysis Population which comprised of all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600K mutation.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 16
Measure Type: Number
Unit of Measure: Participants
Investigator-assessed CR 0
Investigator-assessed PR 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2118436 150 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 13
Confidence Interval (2-Sided) 95%
0.0 to 28.7
Estimation Comments The estimated value represents the percentage of participants with a investigator assessed CR or PR.
3.Secondary Outcome
Title Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation
Hide Description PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or progression minus date of first dose plus 1 day. Kaplan-Meier model was used to estimate the median and 95 percent confidence interval (CI). For participants who received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was censored at the last adequate assessment. For participants who did not have a documented date of progression or death, PFS was censored at the date of last adequate assessment.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 76
Median (95% Confidence Interval)
Unit of Measure: Weeks
6.3
(4.6 to 8.1)
4.Secondary Outcome
Title Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation
Hide Description PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or progression minus date of first dose plus 1 day. Kaplan-Meier model was used to estimate the median and 95 percent CI. For participants who received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was censored at the last adequate assessment. For participants who did not have a documented date of progression or death, PFS was censored at the date of last adequate assessment.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: Weeks
4.0
(2.6 to 6.2)
5.Secondary Outcome
Title Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation
Hide Description Duration of response for participants with either a CR or PR is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. Duration of response was estimated using Kaplan-Meier model and the median and 95 percent CI was presented. The analysis was performed on Primary efficacy Population and only those participants who had a CR or PR were analyzed.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: Weeks
6.6
(3.9 to 11.1)
6.Secondary Outcome
Title Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation
Hide Description Duration of response for participants with either a CR or PR is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. Duration of response was estimated using Kaplan-Meier model and the median and 95 percent CI was presented. The analysis was performed on Secondary efficacy Population and only those participants who had a CR or PR were analyzed.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 3
Median (95% Confidence Interval)
Unit of Measure: Weeks
5.6
(3.7 to 6.8)
7.Secondary Outcome
Title Overall Survival for Participants Who Had a BRAF V600E Mutation
Hide Description Overall survival is defined as the time from the first dose of study medication until death due to any cause. For participants who did not die, overall survival was censored at the date of last contact. Overall survival was estimated using kaplan-Meier model and median and 95 percent CI was presented.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 76
Median (95% Confidence Interval)
Unit of Measure: Weeks
13.1
(9.5 to 21.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2118436 150 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 20
Confidence Interval (2-Sided) 95%
11.6 to 29.8
Estimation Comments The estimated value represents the percentage of participants with overall survival.
8.Secondary Outcome
Title Overall Survival for Participants Who Had a BRAF V600K Mutation
Hide Description Overall survival is defined as the time from the first dose of study medication until death due to any cause. For participants who did not die, overall survival was censored at the date of last contact. Overall survival was estimated using Kaplan-Meier model and median and 95 percent CI was presented.
Time Frame From the first dose to death due to any cause (up to 60 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: Weeks
12.9
(4.2 to 17.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2118436 150 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 13
Confidence Interval (2-Sided) 95%
2.2 to 34.6
Estimation Comments The estimated value represents the percentage of participants with overall survival.
9.Secondary Outcome
Title Number of Participants With AEs and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on All treated Population which comprised of all participants that receive at least one dose of dabrafenib.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 92
Measure Type: Number
Unit of Measure: Participants
Any AE 87
Any SAE 33
10.Secondary Outcome
Title Number of Participants With Change From Baseline in Clinical Chemistry and Hematology Toxicity Grades
Hide Description Blood samples were collected from participants for evaluation of change from Baseline in toxicity grades in clinical chemistry and hematology parameters. The clinical chemistry parameters included alkaline phosphatase, Alanine amino transferase (ALT), Aspartate amino transferase (AST), total bilirubin, creatinine, glucose, potassium, magnesium, sodium and phosphorus. The hematology parameters included hemoglobin, total neutrophils, platelets and white blood cells (WBC). Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst case post-baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 92
Measure Type: Number
Unit of Measure: Participants
Alkaline phosphatase; n= 91 Number Analyzed 91 participants
23
ALT; n= 91 Number Analyzed 91 participants
18
AST; n= 91 Number Analyzed 91 participants
18
Total bilirubin; n= 91 Number Analyzed 91 participants
3
Creatinine; n= 91 Number Analyzed 91 participants
11
Glucose; n= 90 Number Analyzed 90 participants
51
Potassium; n= 91 Number Analyzed 91 participants
2
Magnesium; n= 89 Number Analyzed 89 participants
2
Sodium; n= 91 Number Analyzed 91 participants
5
Phosphorus; n= 91 Number Analyzed 91 participants
36
Hemoglobin; n= 91 Number Analyzed 91 participants
0
Total Neutrophils; n= 91 Number Analyzed 91 participants
21
Platelet; n= 91 Number Analyzed 91 participants
12
WBC; n= 91 Number Analyzed 91 participants
24
11.Secondary Outcome
Title Number of Participants With Change From Baseline in Temperature and Pulse Rate
Hide Description Number of participants with change from Baseline in temperature and pulse rate were evaluated from the first dose of study treatment till discontinuation due to any reason. Change from Baseline in worst-case post Baseline value was presented as decrease to <=35, change to normal or no change and increase to >=38. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst case post-baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 91
Measure Type: Number
Unit of Measure: Participants
Temperature; Decrease to <=35 3
Temperature; Change to normal or no change 84
Temperature; Increase to >=38 4
Pulse rate; Decrease to <=35 9
Pulse rate; Change to normal or no change 66
Pulse rate; Increase to >=38 16
12.Secondary Outcome
Title Number of Participants With Increase From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description Number of participants with increase from Baseline in SBP and DBP were evaluated from the first dose of study treatment till discontinuation due to any reason. Change from Baseline in worst-case post Baseline value was presented as any increase to >=80 and increase to >=100 for DBP and as any increase to >=120 and increase to >=160 for SBP. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst-case post Baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period. One participant out of the 92 participants (76 BRAF V600E patients + 16 BRAF V600K patients) did not have SBP and DBP collected after baseline.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 91
Measure Type: Number
Unit of Measure: Participants
DBP; Any increase to >=80 32
DBP; Increase to >=100 6
SBP; Any icrease to >=120 2
SBP; Increase to >=160 7
13.Secondary Outcome
Title Number of Participants With Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Levels
Hide Description LVEF was defined as the percentage of blood pumped out of the left ventricle. Change from Baseline in worst-case post Baseline was presented as no change or any increase and any decrease values. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst-case post Baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated Population
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description:
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 Participants Analyzed 92
Measure Type: Number
Unit of Measure: Participants
No change or any increase 34
Any decrease 54
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product until death of all participants or a follow-up till 60 months.
Adverse Event Reporting Description SAEs and non-serious AEs were collected in the All Treated Participants Population, comprised of all randomized participants who received at least one dose of study medication, according to the actual treatment received.
 
Arm/Group Title GSK2118436 150 mg
Hide Arm/Group Description 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.
All-Cause Mortality
GSK2118436 150 mg
Affected / at Risk (%)
Total   71/92 (77.17%) 
Hide Serious Adverse Events
GSK2118436 150 mg
Affected / at Risk (%)
Total   33/92 (35.87%) 
Blood and lymphatic system disorders   
Anaemia  1  2/92 (2.17%) 
Thrombocytopenia  1  1/92 (1.09%) 
Cardiac disorders   
Arrhythmia supraventricular  1  1/92 (1.09%) 
Atrial fibrillation  1  1/92 (1.09%) 
Atrial flutter  1  1/92 (1.09%) 
Endocrine disorders   
Hypothyroidism  1  1/92 (1.09%) 
Gastrointestinal disorders   
Intestinal obstruction  1  1/92 (1.09%) 
Nausea  1  1/92 (1.09%) 
Vomiting  1  3/92 (3.26%) 
General disorders   
Adverse drug reaction  1  1/92 (1.09%) 
Chills  1  1/92 (1.09%) 
Non-cardiac chest pain  1  2/92 (2.17%) 
Pyrexia  1  4/92 (4.35%) 
Infections and infestations   
Appendicitis  1  1/92 (1.09%) 
Cellulitis  1  1/92 (1.09%) 
Localised infection  1  1/92 (1.09%) 
Pneumonia  1  1/92 (1.09%) 
Sepsis  1  1/92 (1.09%) 
Urosepsis  1  1/92 (1.09%) 
Injury, poisoning and procedural complications   
Post procedural hematoma  1  1/92 (1.09%) 
Upper limb fracture  1  1/92 (1.09%) 
Investigations   
Amylase increased  1  1/92 (1.09%) 
Lipase increased  1  1/92 (1.09%) 
Liver function test increased  1  1/92 (1.09%) 
Metabolism and nutrition disorders   
Hyponatraemia  1  2/92 (2.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute myeloid leukaemia  1  1/92 (1.09%) 
Basal cell carcinoma  1  5/92 (5.43%) 
Keratoacanthoma  1  1/92 (1.09%) 
Malignant neoplasm of eyelid  1  1/92 (1.09%) 
Myelodysplastic syndrome  1  1/92 (1.09%) 
Squamous cell carcinoma  1  6/92 (6.52%) 
Squamous cell carcinoma of skin  1  3/92 (3.26%) 
Nervous system disorders   
Aphasia  1  1/92 (1.09%) 
Epilepsy  1  1/92 (1.09%) 
Headache  1  3/92 (3.26%) 
Transient ischaemic attack  1  1/92 (1.09%) 
Psychiatric disorders   
Confusional state  1  2/92 (2.17%) 
Mental status changes  1  1/92 (1.09%) 
Renal and urinary disorders   
Acute kidney injury  1  1/92 (1.09%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/92 (1.09%) 
Pleural effusion  1  1/92 (1.09%) 
Pulmonary embolism  1  1/92 (1.09%) 
Social circumstances   
Miscarriage of partner  1  1/92 (1.09%) 
Vascular disorders   
Deep vein thrombosis  1  1/92 (1.09%) 
Haematoma  1  2/92 (2.17%) 
Hypertensive crisis  1  1/92 (1.09%) 
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK2118436 150 mg
Affected / at Risk (%)
Total   83/92 (90.22%) 
Blood and lymphatic system disorders   
Anaemia  1  11/92 (11.96%) 
Lymphopenia  1  7/92 (7.61%) 
Cardiac disorders   
Tachycardia  1  5/92 (5.43%) 
Gastrointestinal disorders   
Abdominal pain  1  7/92 (7.61%) 
Abdominal pain upper  1  7/92 (7.61%) 
Constipation  1  7/92 (7.61%) 
Diarrhoea  1  11/92 (11.96%) 
Nausea  1  19/92 (20.65%) 
Vomiting  1  15/92 (16.30%) 
General disorders   
Asthenia  1  8/92 (8.70%) 
Chills  1  13/92 (14.13%) 
Fatigue  1  22/92 (23.91%) 
Oedema peripheral  1  6/92 (6.52%) 
Pyrexia  1  24/92 (26.09%) 
Infections and infestations   
Bronchitis  1  5/92 (5.43%) 
Nasopharyngitis  1  13/92 (14.13%) 
Investigations   
Blood alkaline phosphatase increased  1  5/92 (5.43%) 
Weight decreased  1  6/92 (6.52%) 
Metabolism and nutrition disorders   
Decreased appetite  1  14/92 (15.22%) 
Hyperglycaemia  1  5/92 (5.43%) 
Hypophosphataemia  1  9/92 (9.78%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  33/92 (35.87%) 
Back pain  1  9/92 (9.78%) 
Musculoskeletal pain  1  8/92 (8.70%) 
Myalgia  1  8/92 (8.70%) 
Pain in extremity  1  15/92 (16.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Melanocytic naevus  1  10/92 (10.87%) 
Seborrhoeic keratosis  1  12/92 (13.04%) 
Skin papilloma  1  15/92 (16.30%) 
Nervous system disorders   
Headache  1  19/92 (20.65%) 
Psychiatric disorders   
Anxiety  1  5/92 (5.43%) 
Depression  1  5/92 (5.43%) 
Insomnia  1  5/92 (5.43%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  12/92 (13.04%) 
Dyspnoea  1  11/92 (11.96%) 
Skin and subcutaneous tissue disorders   
Actinic keratosis  1  8/92 (8.70%) 
Alopecia  1  15/92 (16.30%) 
Dry skin  1  11/92 (11.96%) 
Erythema  1  8/92 (8.70%) 
Hyperhidrosis  1  6/92 (6.52%) 
Hyperkeratosis  1  27/92 (29.35%) 
Palmoplantar keratoderma  1  8/92 (8.70%) 
Pruritus  1  9/92 (9.78%) 
Pruritus generalised  1  5/92 (5.43%) 
Rash  1  10/92 (10.87%) 
Transient acantholytic dermatosis  1  6/92 (6.52%) 
Vascular disorders   
Hot flush  1  6/92 (6.52%) 
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
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.
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.
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
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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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