Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part)
CompletedPhase 2Results postedLast updated 24 July 2017
What this trial tests
Phase 2 trial testing dabrafenib in Solid Tumours in 12 participants. Completed in 4 July 2016.
20 and older, any sex, with Solid Tumours. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)Primary· From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 year)
An AE is defined as any untoward medical occurrence (MO) in a part. temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. SAE is defined as any untoward MO that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect and protocol-specific SAEs:ALT\>=3xup
Any AEs
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
6
Any SAEs
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Phase I: Number of Participants With a Dose-limiting Toxicity (DLT)Primary· From the start of study treatment until 21 days
A DLT was defined as an event occurred during the first 21 days after the first dose of study drugs and met any of the following criteria, according to National Cancer Institutes (NCI) common terminology criteria for AE (CTCAE) grade (G) version 4.0: G4 hematological toxicity; G3 or G4 non-hematologic toxicity (including rash, nausea, vomiting and diarrhea only if uncontrolled with supportive therapy); rash \>=G3 that required dose reduction despite supportive care; a G2 or greater non-hematological toxicity that in the judgment of the investigator and medical monitor; dose interruption of gre
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0
Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs)Primary· From Baseline until the post-treatment Visit (average of 1.38 year)
CCPs were graded according to NCI CTCAE grade version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters (para) for which an increase to G3 or G4 from BL G occurred. CCPs that were not G according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those para for which the category decreased to Low or increased to High relative to the BL category. The worst-case during the on-therapy period was determined taking into account both scheduled and un
Alkaline Phosphatase, G3
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
ALT, G3
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Inorganic Phosphorous, G4
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Chloride, Low
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
2
LDH, Low
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
LDH, High
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
3
Total Protein, Low
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
2
Urea/BUN, Low
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Phase I: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology ParametersPrimary· From Baseline until the post-treatment Visit (average of 1.38 year)
Hematology parameters were summarized according to NCI CTCAE G, version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline G occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period w
Lymphocytes, G3
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Total Neutrophils, G3
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Basophils, High
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Eosinophils, High
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Hematocrit, Low
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
3
MCHC, Low
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
MCH, Low
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
2
MCV, Low
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Phase I: Number of Participants With the Indicated Urinalysis ParametersPrimary· From Baseline until the post-treatment Visit (average of 1.38 year)
Urine samples were collected for urine dipstick analysis at Baseline and at the post-treatment Visit. The number of participants with negative (absence) and positive (presence: trace, 1+, 2+, 3+, 4+ or 5+) results for urine occult blood (UOB), urine glucose (UGLU), urine ketones (UKET), urine protein (UP) and urine urobilinogen (UUBIL) were summarized. The Baseline value is defined as the last pre-treatment value observed.
UOB, Baseline, Negative
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
6
UOB, Baseline, Positive
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0
UOB, Post-Treatment, Negative
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
2
UOB, Post-Treatment, Positive
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
UGLU, Baseline, Negative
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
6
UGLU, Baseline, Positive
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0
UGLU, Post-Treatment, Negative
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
3
UGLU, Post-Treatment, Positive
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0
Phase I: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance (Pef) StatusPrimary· From Baseline until the post-treatment Visit (average of 1.38 year)
The ECOG pef status 5-point scale is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the par. and to determine appropriate treatment and prognosis: G0, fully active, able to carry on all pre-disease pef without restriction. G1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. G2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about \>50 percent (%) of waking hrs. G3, c
Improved
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
No change
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
4
Deteriorated
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Phase I: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3Primary· From Baseline until the post-treatment Visit (average of 1.38 year)
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) values were graded using (NCI CTCAE version 4.0). SBP was categorized as: G1 (Increase to \>=120 to 140 millimeters of mercury \[mmHg\]), G2 (Increase to \>=140 to \<160 mmHg), and G3 (Increase to \>=160 mmHg). DBP was categorized as: G1 (Increase to \>=80 to \<90 mmHg), G2 (Increase to \>=90 to \<100 mmHg), and G3 (Increase to \>=100 mmHg). The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. An increase is defined as an increase in the CTCAE grade relative to
SBP, Increase to Grade 2
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
3
SBP, Increase to Grade 3
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0
DBP, Increase to Grade 2
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
2
DBP, Increase to Grade 3
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Heart RatePrimary· From Baseline until the post-treatment Visit (average of 1.38 year)
Change from Baseline in heart rate is categorized as decrease to \<60 beats per minute (bpm), change to normal or no change, and increase to \>100 bpm relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant's heart rate value decreased to \<60 bpm and increased to \>100 bpm post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.
Decrease to <60 bpm
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Change to normal or no change
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
3
Increase to >100 bpm
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
3
Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in TemperaturePrimary· From Baseline until the post-treatment Visit (average of 1.38 years)
Change from Baseline in temperature is categorized as a decrease to \<=35 degrees celsius (C), change to normal or no change as 35-38 degrees C, and increase to \>=38 degrees C relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to \<=35 degrees C and increased to \>=38 degrees C post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.
Decrease to <=35 degrees C
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
2
Change to normal or no change
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
2
Increase to >=38 degrees C
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
3
Phase I: Change From Baseline in Oxygen Saturation (SpO2) Measured Via Pulse Oxymetry at the Indicated Time PointsPrimary· From Baseline until the post-treatment Visit (average of 1.38 year)
Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen,that is called as blood oxygen saturation or SpO2. Change from Baseline was calculated as the individual post-Baseline value (Days 8,15; Weeks 3 to 136 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.
Day 8, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1.0
± 0.89
Day 15, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0.8
± 0.75
Week 3, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0.2
± 0.75
Week 8, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0.7
± 1.21
Week 12, n=5
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1.4
± 1.67
Week 16, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1.2
± 2.14
Week 20, n=5
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0.4
± 1.14
Week 24, n=5
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0.8
± 1.92
Phase I: Change From Baseline in Weight at the Indicated Time PointsPrimary· From Baseline until the post-treatment Visit ( average of 1.38 year)
Mean change in body weight from Baseline was determined. Change from Baseline was calculated as the individual post-Baseline value (Weeks 3 to 136 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.
Week 3, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
-4.87
± 6.046
Week 8, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
-4.43
± 6.274
Week 12, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
-4.13
± 6.436
Week 16, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
-4.00
± 6.801
Week 20, n=5
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
-0.62
± 2.295
Week 24, n=5
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
-0.70
± 1.402
Week 28, n=5
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
-0.36
± 1.850
Week 32, n=5
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
-0.38
± 1.809
Phase I: Number of Participants With the Indicated Electrocardiogram (ECG) Findings at the Indicated Time PointsPrimary· From Baseline until the post-treatment Visit (average of 1.38 year)
Single twelve (12)-lead ECGs were perfomred at Baseline, Weeks 3 to 132 and post-treatment Visit. ECG findings were categorized as: normal, abnormal - clinically significant (CS), or abnormal - not clinically significant (NCS), as determined by the investigator.
Baseline, Normal, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
4
Baseline, Abnormal-NCS, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
2
Baseline, Abnormal-CS, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0
Week 3, Normal, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
5
Week 3, Abnormal-NCS, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Week 3, Abnormal-CS, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
0
Week 12, Normal, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
5
Week 12, Abnormal-NCS, n=6
Group
Value
95% CI
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
1
Adverse events — posted to ClinicalTrials.gov
Time frame: On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of investigational product (IP) until 30 days after the last dose of IP (average of 1.38 years)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600E/K mutation positive advanced solid tumors (Phase I part) and BRAF V600E/K mutation positive cutaneous melanoma (Phase II part).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04961619 — Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.
· completed
NCT05299580 — "Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II
· Phase 2
· withdrawn
NCT04666272 — Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With St
· active not recruiting
NCT03975829 — Pediatric Long-Term Follow-up and Rollover Study
· Phase 4
· active not recruiting
NCT03553329 — Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti B
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 24 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01928940.