NCT01072175 is a Phase 2 clinical trial of GSK2118436 in Cancer, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01072175?

NCT01072175 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01072175?

Interventions in NCT01072175: GSK2118436, GSK1120212.

Is NCT01072175 still recruiting?

NCT01072175 is currently completed. Last updated 5 July 2019.

Are results published for NCT01072175?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-07-05 · How we verify

NCT01072175

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212

Completed Phase 2 Results posted Last updated 5 July 2019

What this trial tests

Phase 2 trial testing GSK2118436 in Cancer in 430 participants. Completed in 27 February 2018.

Timeline

26 March 2010

Primary endpoint
31 May 2012

27 February 2018

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Masking	none
Primary purpose	treatment
Enrollment	430
Start date	26 March 2010
Primary completion	31 May 2012
Estimated completion	27 February 2018
Sites	15 locations across United States, Australia

Drugs / interventions tested

GSK2118436 — full drug profile →
GSK1120212 — full drug profile →

Conditions studied

Cancer — all drugs for Cancer →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Cancer. 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.

Part A: Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib Primary · Day 15

Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.

GSK2118436

Group	Value	95% CI
Part A: Dabrafenib 75 mg	509	379 – 685
Part A: Dabrafenib 75 mg + Trametinib 2 mg	524	390 – 705

GSK2285403

Group	Value	95% CI
Part A: Dabrafenib 75 mg	259	190 – 352
Part A: Dabrafenib 75 mg + Trametinib 2 mg	255	196 – 331

GSK2298683

Group	Value	95% CI
Part A: Dabrafenib 75 mg	724	595 – 879
Part A: Dabrafenib 75 mg + Trametinib 2 mg	747	587 – 951

GSK2167542

Group	Value	95% CI
Part A: Dabrafenib 75 mg	8.37	4.82 – 14.5
Part A: Dabrafenib 75 mg + Trametinib 2 mg	8.16	5.68 – 11.7

Part A: AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites Primary · Day 15

Blood samples for PK analysis of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. AUC is defined as the area under the dabrafenib concentration-time curve as a measure of drug exposure. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC (0-t) is defined as area under the concentration-time curve from time zero (pre-dose) to the last

GSK2118436 AUC (0-t)

Group	Value	95% CI
Part A: Dabrafenib 75 mg	2734	2205 – 3390
Part A: Dabrafenib 75 mg + Trametinib 2 mg	2751	2219 – 3411

GSK2118436 AUC (0-inf)

Group	Value	95% CI
Part A: Dabrafenib 75 mg	3128	2578 – 3797
Part A: Dabrafenib 75 mg + Trametinib 2 mg	2949	2445 – 3556

GSK2285403 AUC (0-t)

Group	Value	95% CI
Part A: Dabrafenib 75 mg	2232	1684 – 2959
Part A: Dabrafenib 75 mg + Trametinib 2 mg	2287	1899 – 2753

GSK2285403 AUC (0-inf)

Group	Value	95% CI
Part A: Dabrafenib 75 mg	2819	2231 – 3562
Part A: Dabrafenib 75 mg + Trametinib 2 mg	2497	2097 – 2974

GSK2298683 AUC (0-t)

Group	Value	95% CI
Part A: Dabrafenib 75 mg	12761	10347 – 15738
Part A: Dabrafenib 75 mg + Trametinib 2 mg	13053	10475 – 16266

GSK2167542 AUC (0-t)

Group	Value	95% CI
Part A: Dabrafenib 75 mg	270	188 – 390
Part A: Dabrafenib 75 mg + Trametinib 2 mg	276	230 – 332

Part B: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Primary · From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.

Any AE

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	6
Part B: Dabrafenib 150 mg + Trametinib 1 mg	23
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	27
Part B: Dabrafenib 150 mg + Trametinib 2 mg	93

Any SAE

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	15
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	14
Part B: Dabrafenib 150 mg + Trametinib 2 mg	55

Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline Primary · From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)

Clinical Chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.

Albumin

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	1
Part B: Dabrafenib 150 mg + Trametinib 2 mg	3
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Alkaline Phosphatase

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	1
Part B: Dabrafenib 150 mg + Trametinib 2 mg	10
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Alanine Amino Transferase

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	1
Part B: Dabrafenib 150 mg + Trametinib 2 mg	2
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Amylase

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Aspartate Amino Transferase

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	1
Part B: Dabrafenib 150 mg + Trametinib 2 mg	5
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Total Bilirubin

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	2
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Calcium (Hypercalcemia)

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Calcium (Hypocalcemia)

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	1
Part B: Dabrafenib 150 mg + Trametinib 2 mg	1
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	1

Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range Primary · From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)

For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.

Direct Bilirubin

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Indirect Bilirubin

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Creatine Kinase MB mass

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Chloride

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	4
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	10
Part B: Dabrafenib 150 mg + Trametinib 2 mg	39
Part B: Dabrafenib 75 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1 mg	11
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	8
Part B: Dabrafenib 150 mg + Trametinib 2 mg	16

Carbon dioxide content/Bicarbonate

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	4
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	6
Part B: Dabrafenib 150 mg + Trametinib 2 mg	16
Part B: Dabrafenib 75 mg + Trametinib 1 mg	3
Part B: Dabrafenib 150 mg + Trametinib 1 mg	7
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	11
Part B: Dabrafenib 150 mg + Trametinib 2 mg	25

Creatinine clearance

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1 mg	4
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	10
Part B: Dabrafenib 150 mg + Trametinib 2 mg	19
Part B: Dabrafenib 75 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1 mg	5
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	5
Part B: Dabrafenib 150 mg + Trametinib 2 mg	8

Lactate dehydrogenase

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	1
Part B: Dabrafenib 150 mg + Trametinib 2 mg	4
Part B: Dabrafenib 75 mg + Trametinib 1 mg	4
Part B: Dabrafenib 150 mg + Trametinib 1 mg	9
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	11
Part B: Dabrafenib 150 mg + Trametinib 2 mg	35

Total protein

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	10
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	10
Part B: Dabrafenib 150 mg + Trametinib 2 mg	30
Part B: Dabrafenib 75 mg + Trametinib 1 mg	3
Part B: Dabrafenib 150 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	1
Part B: Dabrafenib 150 mg + Trametinib 2 mg	7

Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline Primary · From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)

Hematology parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.

Hemoglobin (Increased)

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Hemoglobin (Anemia)

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	3
Part B: Dabrafenib 150 mg + Trametinib 2 mg	10
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Lymphocytes (Increased)

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Lymphocytes (Decreased)

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	7
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	4
Part B: Dabrafenib 150 mg + Trametinib 2 mg	19
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	4
Part B: Dabrafenib 150 mg + Trametinib 2 mg	5

Total Neutrophils

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	3
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	3
Part B: Dabrafenib 150 mg + Trametinib 2 mg	10
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Platelet Count

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	2
Part B: Dabrafenib 150 mg + Trametinib 2 mg	1
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	1

White Blood Cell Count

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	4
Part B: Dabrafenib 150 mg + Trametinib 2 mg	8
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	0

Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range Primary · From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)

For Hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject "Decreased to Low" and Increase to High" during the post-baseline period. Only descriptive analysis.

Basophils

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	0
Part B: Dabrafenib 150 mg + Trametinib 2 mg	2
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	4
Part B: Dabrafenib 150 mg + Trametinib 2 mg	7

Eosinophils

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	5
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	6
Part B: Dabrafenib 150 mg + Trametinib 2 mg	28
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	5
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	7
Part B: Dabrafenib 150 mg + Trametinib 2 mg	11

Hematocrit

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	5
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	7
Part B: Dabrafenib 150 mg + Trametinib 2 mg	24
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	2
Part B: Dabrafenib 150 mg + Trametinib 2 mg	2

Mean Corpuscle Hemoglobin concentration

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	6
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	11
Part B: Dabrafenib 150 mg + Trametinib 2 mg	21
Part B: Dabrafenib 75 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1 mg	4
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	5
Part B: Dabrafenib 150 mg + Trametinib 2 mg	13

Mean Corpuscle Hemoglobin

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	6
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	8
Part B: Dabrafenib 150 mg + Trametinib 2 mg	12
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	3
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	6
Part B: Dabrafenib 150 mg + Trametinib 2 mg	11

Mean Corpuscle Volume

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	5
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	6
Part B: Dabrafenib 150 mg + Trametinib 2 mg	13
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	4
Part B: Dabrafenib 150 mg + Trametinib 2 mg	5

Monocytes

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1 mg	8
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	10
Part B: Dabrafenib 150 mg + Trametinib 2 mg	21
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	4
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	9
Part B: Dabrafenib 150 mg + Trametinib 2 mg	30

Red Blood Cell count

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	9
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	5
Part B: Dabrafenib 150 mg + Trametinib 2 mg	25
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	1
Part B: Dabrafenib 150 mg + Trametinib 2 mg	2

Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure Primary · From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)

Blood pressure and heart rate were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Blood pressure measurement included systolic blood pressure (SBP, millimeters of mercury \[mmHg\]) and diastolic BP (DBP). Heart rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to \<60 bpm, change to normal or no change, or increase to \>100 bpm are presented.

Heart rate, Decrease to <60 bpm

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	5
Part B: Dabrafenib 150 mg + Trametinib 2 mg	15

Heart rate, Change to normal or no change

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	3
Part B: Dabrafenib 150 mg + Trametinib 1 mg	14
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	15
Part B: Dabrafenib 150 mg + Trametinib 2 mg	37

Heart rate, Increase to >100 bpm

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1 mg	7
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	8
Part B: Dabrafenib 150 mg + Trametinib 2 mg	26

SBP, Increase to G3 or G4

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	2
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	3
Part B: Dabrafenib 150 mg + Trametinib 2 mg	8

DBP, Increase to G3 or G4

Group	Value	95% CI
Part B: Dabrafenib 75 mg + Trametinib 1 mg	0
Part B: Dabrafenib 150 mg + Trametinib 1 mg	1
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg	3
Part B: Dabrafenib 150 mg + Trametinib 2 mg	4

Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator Primary · From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)

Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters \[mm\] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for re

Group	Value	95% CI
Part C: Dabrafenib 150 mg	2
Part C: Dabrafenib 150 mg + Trametinib 1 mg	6
Part C: Dabrafenib 150 mg + Trametinib 2 mg	10

Group	Value	95% CI
Part C: Dabrafenib 150 mg	27
Part C: Dabrafenib 150 mg + Trametinib 1 mg	21
Part C: Dabrafenib 150 mg + Trametinib 2 mg	31

Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response Assessed by Blinded Independent Central Review (BICR) Primary · From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 19 months)

Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were firs

Group	Value	95% CI
Part C: Dabrafenib 150 mg	4
Part C: Dabrafenib 150 mg + Trametinib 1 mg	4
Part C: Dabrafenib 150 mg + Trametinib 2 mg	7

Group	Value	95% CI
Part C: Dabrafenib 150 mg	21
Part C: Dabrafenib 150 mg + Trametinib 1 mg	18
Part C: Dabrafenib 150 mg + Trametinib 2 mg	26

Part C (Crossover): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator Primary · From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)

Group	Value	95% CI
Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg	1

Group	Value	95% CI
Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg	5

Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Investigator Primary · From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)

PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute i

Group	Value	95% CI
Part C: Dabrafenib 150 mg	5.8	4.3 – 7.4
Part C: Dabrafenib 150 mg + Trametinib 1 mg	9.2	5.7 – 11.0
Part C: Dabrafenib 150 mg + Trametinib 2 mg	9.4	7.6 – 16.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 90 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: Dabrafenib 75 mg + Trametinib 2 mg

Serious: 5/8 (63%)

Deaths: 2/8

Part B: Dabrafenib 75 mg + Trametinib 1 mg

Serious: 1/6 (17%)

Deaths: 0/6

Part B: Dabrafenib 150 mg + Trametinib 1 mg

Serious: 15/23 (65%)

Deaths: 1/23

Part B: Dabrafenib 150 mg + Trametinib 1.5 mg

Serious: 14/27 (52%)

Deaths: 6/27

Part B: Dabrafenib 150 mg + Trametinib 2 mg

Serious: 55/94 (59%)

Deaths: 12/94

Part C (Randomized): Dabrafenib 150 mg

Serious: 15/53 (28%)

Deaths: 1/53

Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg

Serious: 24/54 (44%)

Deaths: 4/54

Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg

Serious: 39/55 (71%)

Deaths: 7/55

Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg

Serious: 24/45 (53%)

Deaths: 7/45

Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg

Serious: 8/15 (53%)

Deaths: 1/15

Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg

Serious: 11/15 (73%)

Deaths: 4/15

Part D: Dabrafenib 75 mg + Trametinib 2 mg

Serious: 29/41 (71%)

Deaths: 7/41

Part D: Dabrafenib 150 mg + Trametinib 2 mg

Serious: 30/39 (77%)

Deaths: 2/39

Serious adverse events (223 terms)

Reaction	System	Part A: Dabrafenib 75 mg +…	Part B: Dabrafenib 75 mg +…	Part B: Dabrafenib 150 mg …	Part B: Dabrafenib 150 mg …	Part B: Dabrafenib 150 mg …	Part C (Randomized): Dabra…	Part C (Randomized): Dabra…	Part C (Randomized): Dabra…	Part C (Crossover): Dabraf…	Part D: Dabrafenib (DAB) 7…	Part D: Dabrafenib 150 mg …	Part D: Dabrafenib 75 mg +…	Part D: Dabrafenib 150 mg …
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Ejection fraction decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—
Cytokine release syndrome	Immune system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Large intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (354 terms — click to expand)

Reaction	System	Part A: Dabrafenib 75 mg +…	Part B: Dabrafenib 75 mg +…	Part B: Dabrafenib 150 mg …	Part B: Dabrafenib 150 mg …	Part B: Dabrafenib 150 mg …	Part C (Randomized): Dabra…	Part C (Randomized): Dabra…	Part C (Randomized): Dabra…	Part C (Crossover): Dabraf…	Part D: Dabrafenib (DAB) 7…	Part D: Dabrafenib 150 mg …	Part D: Dabrafenib 75 mg +…	Part D: Dabrafenib 150 mg …
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperkeratosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Actinic keratosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dermatitis acneiform	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Pyrexia, Chills, Ejection fraction decreased, Hypotension, Squamous cell carcinoma of skin, Cytokine release syndrome, Basal cell carcinoma, Vomiting.

Data from ClinicalTrials.gov NCT01072175 adverse events section.

Sponsor's own description

This was an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This study was designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the pharmacokinetics of single dose GSK2118436 was investigated prior to evaluating combination regimens. In Part B, the range of tolerated dose combinations was identified using a dose-escalation procedure. In Part C, different dose combinations of GSK2118436 and GSK1120212 were evaluated, based on results from the dose escalation cohorts. In Part D, the pharmacokinetics and safety of GSK2118436 administered as HPMC capsules alone and in combination with GSK1120212 was evaluated.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations.
Flaherty KT, Infante JR, Daud A, Gonzalez R, et al · · 2012 · cited 2094× · PMID 23020132 · DOI 10.1056/nejmoa1210093
The MAPK pathway across different malignancies: a new perspective.
Burotto M, Chiou VL, Lee JM, Kohn EC. · · 2014 · cited 773× · PMID 24948110 · DOI 10.1002/cncr.28864
Dabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase 1 dose-escalation trial.
Falchook GS, Long GV, Kurzrock R, Kim KB, et al · · 2012 · cited 707× · PMID 22608338 · DOI 10.1016/s0140-6736(12)60398-5
Robust prediction of response to immune checkpoint blockade therapy in metastatic melanoma.
Auslander N, Zhang G, Lee JS, Frederick DT, et al · · 2018 · cited 586× · PMID 30127394 · DOI 10.1038/s41591-018-0157-9
Combined BRAF and MEK Inhibition With Dabrafenib and Trametinib in BRAF V600-Mutant Colorectal Cancer.
Corcoran RB, Atreya CE, Falchook GS, Kwak EL, et al · · 2015 · cited 396× · PMID 26392102 · DOI 10.1200/jco.2015.63.2471
Phase II study of the MEK1/MEK2 inhibitor Trametinib in patients with metastatic BRAF-mutant cutaneous melanoma previously treated with or without a BRAF inhibitor.
Kim KB, Kefford R, Pavlick AC, Infante JR, et al · · 2013 · cited 365× · PMID 23248257 · DOI 10.1200/jco.2012.43.5966
Clinical, pathologic, and biologic features associated with BRAF mutations in non-small cell lung cancer.
Cardarella S, Ogino A, Nishino M, Butaney M, et al · · 2013 · cited 284× · PMID 23833300 · DOI 10.1158/1078-0432.ccr-13-0657
Ras/Raf/MEK/ERK and PI3K/PTEN/Akt/mTOR cascade inhibitors: how mutations can result in therapy resistance and how to overcome resistance.
McCubrey JA, Steelman LS, Chappell WH, Abrams SL, et al · · 2012 · cited 242× · PMID 23085539 · DOI 10.18632/oncotarget.659

Verify or expand the search:

Other trials of GSK2118436

Trials testing the same drug.

NCT01582997 — A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of of GSK2118436 in Japanese Subject · Phase 1 · completed
NCT01340833 — Determination of the Absolute Bioavailability of GSK2118436 Following a Single Oral Dose Co-Administered With an Intrave · Phase 1 · completed
NCT01262963 — An Absorption, Distribution, Metabolism and Excretion (ADME) Study of Single Oral Dose [14C] GSK2118436 in Subjects With · Phase 1 · completed
NCT01227889 — A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced · Phase 3 · completed
NCT01231594 — A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors · Phase 1 · completed

Other recruiting trials for Cancer

Currently open trials in the same condition.

NCT07390045 — Exercise and Cognitive Rehabilitation Interventions for Older Cancer Survivors · NA · recruiting
NCT07528547 — Hypersight and Ethos In Pediatric Radiotherapy · NA · recruiting
NCT07481890 — Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients. · NA · recruiting
NCT07402057 — Implementation and Evaluation of a Program Aimed at Facilitating Palliative Care Conversations · NA · recruiting
NCT07305740 — On-Trac: An Online Intervention for Cancer Survivors Managing Anxiety · NA · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01072175 (US National Library of Medicine, public domain)
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 Novartis Pharmaceuticals
Last refreshed: 5 July 2019

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/NCT01072175.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing