Clinical trials: Trametinib, completed
Cancer
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212
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.
- Trial name
- NCT01072175
- Testing
- GSK2118436, GSK1120212
- Where
- 15 sites in United States, Australia
- Volunteers
- 430 people
- Sponsor
- Novartis Pharmaceuticals
Lung Cancer, Non-Small Cell
An Open-label Study of GSK1120212 Compared With Docetaxel in Stage IV KRAS-mutant Non-small Cell Lung Cancer
This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV)…
- Trial name
- NCT01362296
- Testing
- GSK1120212, docetaxel
- Where
- 60 sites in United States, France and 6 more
- Volunteers
- 134 people
- Sponsor
- GlaxoSmithKline
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
Cancer
Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias
MEK111759 is a dose-escalation, Phase I/II, open-label study to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 in subjects with relapsed or refractory leukemias.
- Trial name
- NCT00920140
- Testing
- GSK1120212
- Where
- 28 sites in United States, Belgium and 2 more
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
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
Melanoma
An Open-Label Phase II Study of the Combination of GSK2118436 and GSK1120212 in Patients With Metastatic Melanoma Which is Refractory or Resistant to BRAF Inhibitor
The goal of this clinical research study is to learn if the combination of 2 drugs dabrafenib and trametinib can help to control melanoma that has or has not spread to the brain.
- Trial name
- NCT01619774
- Testing
- GSK2118436, GSK1120212
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- M.D. Anderson Cancer Center
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
Ameloblastoma, BRAF Gene Mutation
Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma
This pilot clinical trial studies dabrafenib and trametinib in treating patients with ameloblastoma and a specific mutation (change) in the BRAF gene.
- Trial name
- NCT02367859
- Testing
- Dabrafenib, Trametinib
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stanford University
Estrogen Receptor Negative, HER2/Neu Negative
Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-Negative Breast Cancer
This phase II trial studies how well trametinib and v-akt murine thymoma viral oncogene homolog 1 (Akt) inhibitor GSK2141795 work in treating patients with triple-negative breast cancer (breast cancer cells that do not have…
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative
- Trial name
- NCT01964924
- Testing
- Akt Inhibitor GSK2141795, Laboratory Biomarker Analysis, Trametinib
- Where
- 8 sites in United States
- Volunteers
- 37 people
- Sponsor
- National Cancer Institute (NCI)
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
Non Small Cell Lung Cancer, KRAS Gene Mutation
Trial of Trametinib and Ponatinib in Patients With KRAS Mutant Advanced Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the safety of the combination of ponatinib and trametinib as well as the most appropriate dosages of the combination.
- Trial name
- NCT03704688
- Testing
- Trametinib 0.5 mg, Trametinib 1 MG, Trametinib 1.5 MG
- Where
- 7 sites in United States
- Volunteers
- 12 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
Stage III Melanoma, Stage IV Melanoma
LCCC 1128: Open Label Phase II Trial of the BRAF Inhibitor (Dabrafenib) and the MEK Inhibitor (Trametinib) in Unresectable Stage III and Stage IV BRAF Mutant Melanoma; Correlation of Resistance With the Kinome and Functional Mutations
This phase II study in 20 patients with BRAFV600E mutant, unresectable stage III/IV melanoma is designed to explore the mechanisms by which tumors acquire resistance to the combination of a BRAF inhibitor (dabrafenib) and MEK…
- Conditions
- Stage III Melanoma, Stage IV Melanoma, Unresectable Melanoma, BRAF Mutant Melanoma
- Trial name
- NCT01726738
- Testing
- BRAF inhibitor dabrafenib and MEK inhibitor trametinib
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Melanoma
Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.
- Trial name
- COMBI-v (NCT01597908)
- Testing
- Dabrafenib, Vemurafenib, Trametinib
- Where
- 205 sites in United States, Argentina and 26 more
- Volunteers
- 704 people
- Sponsor
- Novartis Pharmaceuticals
Cancer
Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer
GSK1120212 is a potent and highly selective inhibitor of MEK phosphorylation and kinase activity and has demonstrated potent anti-proliferative activity against human pancreatic cancer cell lines.
- Trial name
- NCT01231581
- Testing
- GSK1120212, Gemcitabine
- Where
- 7 sites in South Korea, Taiwan
- Volunteers
- 160 people
- Sponsor
- GlaxoSmithKline
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
Diffuse Astrocytoma, Anaplastic Astrocytoma
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high…
- Conditions
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood
- Trial name
- NCT02684058
- Testing
- Dabrafenib, trametinib, Carboplatin
- Where
- 57 sites in United States, Argentina and 18 more
- Volunteers
- 151 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced Epithelioid Hemangioendothelioma, Metastatic Epithelioid Hemangioendothelioma
Trametinib in Treating Patients With Epithelioid Hemangioendothelioma That is Metastatic, Locally Advanced, or Cannot Be Removed by Surgery
This phase II trial studies how well trametinib works in treating patients with epithelioid hemangioendothelioma that has spread to other places in the body (metastatic), nearby tissue or lymph nodes (locally advanced), or cannot…
- Conditions
- Locally Advanced Epithelioid Hemangioendothelioma, Metastatic Epithelioid Hemangioendothelioma, Unresectable Epithelioid Hemangioendothelioma
- Trial name
- NCT03148275
- Testing
- Questionnaire Administration, Trametinib
- Where
- 36 sites in United States
- Volunteers
- 44 people
- Sponsor
- National Cancer Institute (NCI)
Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia
Azacitidine, Venetoclax, and Trametinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome
This phase II trial investigates how well azacitidine, venetoclax, and trametinib work in treating patients with acute myeloid leukemia or higher-risk myelodysplastic syndrome that has come back (relapsed) or has not responded to…
- Conditions
- Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Acute Myeloid Leukemia
- Trial name
- NCT04487106
- Testing
- Azacitidine, Trametinib, Venetoclax
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- M.D. Anderson Cancer Center
Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma
Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery.
- Conditions
- Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma, BCLC Stage D Adult Hepatocellular Carcinoma
- Trial name
- S1310 (NCT02042443)
- Testing
- Capecitabine, Fluorouracil, Laboratory Biomarker Analysis
- Where
- 295 sites in United States
- Volunteers
- 53 people
- Sponsor
- National Cancer Institute (NCI)