Clinical trials: MEK Mutation
Cancer
Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
This was a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors.
- Trial name
- NCT02124772
- Testing
- Trametinib, Dabrafenib
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 139 people
- Sponsor
- Novartis Pharmaceuticals
N-Ras Mutated Locally Advanced or Metastasis Malignant Cutaneous Melanoma
Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma
This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or…
- Trial name
- NCT01693068
- Testing
- Pimasertib, Dacarbazine
- Where
- 101 sites in United States, Australia and 12 more
- Volunteers
- 194 people
- Sponsor
- EMD Serono
Recurrent Melanoma, Stage IIIB Melanoma
Trametinib in Treating Patients With Advanced Melanoma With BRAF Non-V600 Mutations
This phase II trial studies trametinib in treating patients with melanoma with v-Raf murine sarcoma viral oncogene homolog B (BRAF) non-V600 mutations that has spread to other places in the body.
- Conditions
- Recurrent Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma
- Trial name
- NCT02296112
- Testing
- trametinib, laboratory biomarker analysis, pharmacological study
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors
This phase Ib/II trial studies the side effects and best dose of trametinib and navitoclax and how well they work in treating patients with solid tumors that have spread to other places in the body (advanced or metastatic).
- Conditions
- Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
- Trial name
- NCT02079740
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 2 sites in United States
- Volunteers
- 96 people
- Sponsor
- National Cancer Institute (NCI)
Melanoma and Brain Metastases
Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites
This is a global, multi-centre, open-label, study of GSK2118436 conducted in up to 30 evaluable subjects with resectable, BRAF V600E or V600K mutation-positive metastatic melanoma to the brain.
- Trial name
- NCT01978236
- Testing
- Dabrafenib 150 mg, Trametinib 2.0 mg
- Where
- 3 sites in United States, Australia
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Advanced Tumors, Melanoma
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patient With Advanced Tumors
This is a First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patients with Advanced Tumors, composed of a Phase I dose escalation and dose expansion stage and a…
- Conditions
- Advanced Tumors, Melanoma, Non-Small-Cell Lung Cancer, Erdheim-Chester Disease
- Trial name
- NCT04198818
- Testing
- HH2710
- Where
- 3 sites in United States, China
- Volunteers
- 37 people
- Sponsor
- Haihe Biopharma Co., Ltd.
Bile Duct Cancer, Biliary Cancer
Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).
Background: Bile duct cancer is cancer of the slender tubes of the biliary tract. These tubes carry bile through the liver. Such cancer tumors often have an abnormal or mutated gene.
- Conditions
- Bile Duct Cancer, Biliary Cancer, Biliary Tract Neoplasms, Cholangiocarcinoma
- Trial name
- NCT04566133
- Testing
- Trametinib, Hydroxychloroquine
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- National Cancer Institute (NCI)
Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma
Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment
This phase I/II trial investigates the best dose, possible benefits and/or side effects of tazemetostat in combination with dabrafenib and trametinib in treating patients with melanoma that has a specific mutation in the BRAF…
- Trial name
- NCT04557956
- Testing
- Biopsy Procedure, Computed Tomography, Dabrafenib Mesylate
- Where
- 17 sites in United States
- Volunteers
- 16 people
- Sponsor
- National Cancer Institute (NCI)
Malignant Melanoma
A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma.
- Trial name
- NCT01271803
- Testing
- Cobimetinib, vemurafenib
- Where
- 10 sites in United States, Australia
- Volunteers
- 131 people
- Sponsor
- Hoffmann-La Roche
Metastatic Colorectal Cancer
MEK Inhibitor MSC1936369B Plus FOLFIRI in Second Line K-Ras Mutated Metastatic Colorectal Cancer (mCRC)
The research trial is testing the experimental treatment pimasertib (MSC1936369B) in combination with FOLFIRI, as second-line treatment in metastatic K Ras mutated colorectal cancer subjects.
- Trial name
- NCT01085331
- Testing
- Pimasertib, FOLFIRI
- Where
- 3 sites in Belgium, Italy and 1 more
- Volunteers
- 16 people
- Sponsor
- EMD Serono
Recurrent Adult Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Acute Myeloid Leukemia
This phase II trial studies how well trametinib and protein kinase B (Akt) inhibitor GSK2141795 work in treating patients with acute myeloid leukemia.
- Trial name
- NCT01907815
- Testing
- Akt Inhibitor GSK2141795, Laboratory Biomarker Analysis, Trametinib
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- National Cancer Institute (NCI)
Cancer
Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.
This was a Phase II, multicenter, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects…
- Trial name
- NCT01336634
- Testing
- Dabrafenib, Trametinib
- Where
- 50 sites in United States, France and 9 more
- Volunteers
- 177 people
- Sponsor
- Novartis Pharmaceuticals
Gastrointestinal Cancer
Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies
This research study is for patients with an advanced cancer that carries a mutation in a gene called KRAS. Genes are parts of our DNA which carry instructions for a cell (the smallest component of an body part).
- Trial name
- MEKiAUTO (NCT04214418)
- Testing
- Cobimetinib, Hydroxychloroquine, Atezolizumab
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- Columbia University
Metastatic or Unresectable Cutaneous Melanoma
Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma
Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC)…
- Trial name
- NCT01763164
- Testing
- MEK162, Dacarbazine
- Where
- 229 sites in United States, Argentina and 25 more
- Volunteers
- 402 people
- Sponsor
- Pfizer
Cancer
Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor
MEK113583 is a Phase II open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive melanoma who were previously treated with or…
- Trial name
- NCT01037127
- Testing
- GSK1120212
- Where
- 10 sites in United States, Australia
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
Cancer
BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)
This was a four part, phase I/II study aimed to evaluate the safety, tolerability and efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor (dabrafenib (D); GSK2118436) alone or with the…
- Trial name
- NCT01750918
- Testing
- Dabrafenib, Trametinib, Panitumumab
- Where
- 20 sites in United States, Belgium and 6 more
- Volunteers
- 166 people
- Sponsor
- Novartis Pharmaceuticals
BRAF V600E Mutation Present, Papillary Craniopharyngioma
Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma.
- Trial name
- NCT03224767
- Testing
- Vemurafenib, Cobimetinib, Laboratory Biomarker Analysis
- Where
- 106 sites in United States
- Volunteers
- 24 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Melanoma
A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma
This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy).
- Trial name
- NCT01584648
- Testing
- Dabrafenib, Trametinib
- Where
- 121 sites in United States, Argentina and 12 more
- Volunteers
- 423 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus 2 placebos in the adjuvant treatment of melanoma after surgical resection.
- Trial name
- COMBI-AD (NCT01682083)
- Testing
- Dabrafenib, Trametinib
- Where
- 168 sites in United States, Argentina and 23 more
- Volunteers
- 870 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma.
- Trial name
- NCT01245062
- Testing
- GSK1120212, Chemotherapy
- Where
- 112 sites in United States, Argentina and 17 more
- Volunteers
- 322 people
- Sponsor
- GlaxoSmithKline