Clinical trials: Dabrafenib
Cancer
A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors
GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors.
- Trial name
- NCT01340846
- Testing
- Warfarin, Ketoconazole, Gemfibrozil
- Where
- 11 sites in United States, Australia and 1 more
- Volunteers
- 48 people
- Sponsor
- GlaxoSmithKline
Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma
This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB/C/D melanoma, who do not achieve a pathologic complete response after…
- Conditions
- Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8
- Trial name
- NCT04310397
- Testing
- Dabrafenib, Spartalizumab, Therapeutic Conventional Surgery
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- M.D. Anderson Cancer Center
BRAF NP_004324.2:p.V600E, BRAF V600K Mutation Present
Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer
This trial studies how well dabrafenib, trametinib, and intensity modulated radiation therapy (IMRT) work together in treating patients with BRAF mutated anaplastic thyroid cancer.
- Conditions
- BRAF NP_004324.2:p.V600E, BRAF V600K Mutation Present, Thyroid Gland Anaplastic Carcinoma
- Trial name
- NCT03975231
- Testing
- Dabrafenib, Intensity-Modulated Radiation Therapy, Trametinib
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- City of Hope Medical Center
BRAF V600 Mutated-Stage III/IV Melanoma
Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma
This was a retrospective chart review study of all proto-oncogene B-Raf (BRAF) V600-mutated patients who received adjuvant checkpoint inhibitor (CPI) therapy, relapsed locoregionally or distantly, and were again resected to no…
- Trial name
- NCT06557291
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Novartis
NSCLC, BRAF V600E Mutation
Evaluate the Efficacy and Safety of Aspirin in Combination With Trametinib and Dabrafenib
The purpose of this study is to observe the safety and efficacy of Aspirin combined with Trametinib and Dalafenib in the treatment of advanced BRAF V600E mutated non-small cell lung cancer (NSCLC)
- Conditions
- NSCLC, BRAF V600E Mutation, Advanced Cancer, Stage IIIB NSCLC
- Trial name
- NCT05988697
- Testing
- Combind asprin with Trametinib and Dabrafenib
- Volunteers
- 36 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
BRAF Gene Mutation, Hepatic Complication
Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction
This phase I trial studies the side effects and best dose of dabrafenib in treating patients with solid tumors and kidney or liver dysfunction.
- Conditions
- BRAF Gene Mutation, Hepatic Complication, Renal Failure, Solid Neoplasm
- Trial name
- NCT01907802
- Testing
- Dabrafenib, Laboratory Biomarker Analysis, Pharmacogenomic Study
- Where
- 18 sites in United States, Canada
- Volunteers
- 8 people
- Sponsor
- National Cancer Institute (NCI)
Radioiodine-refractory Differentiated Thyroid Cancer
A Real-World Study of Second-line Therapies Among Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC) Patients
This study aims to assess patient characteristics and treatment patterns of second-line systematic therapies, including BRAF V600E mutation-guided dabrafenib plus trametinib (D+T) and MKIs, among Chinese adult patients with RAI-R…
- Trial name
- NCT07770074
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients
The main purpose is to evaluate the clinical response, safety and survival of the FDA approved drugs Dabrafenib, Trametinib in combination with Metformin.
- Trial name
- NCT02143050
- Testing
- Dabrafenib, Trametinib, Metformin
- Where
- 2 sites in United States
- Sponsor
- University of Louisville
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
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
This phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and…
- Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Recurrent Melanoma
- Trial name
- NCT02224781
- Testing
- Biospecimen Collection, Computed Tomography, Dabrafenib Mesylate
- Where
- 838 sites in United States
- Volunteers
- 267 people
- Sponsor
- National Cancer Institute (NCI)
Pyrexia
Pyrexia Management Using an IL-6 Antibody in BRAF+ Melanoma Patients Treated with Dabrafenib/ Trametinib +/- Immunotherapy
The study examines the development of fever after administration of Actemra (tocilizumab) in patients who have fever and other cytokine release symptoms (headache, nausea, palpitations, low blood pressure) due to cancer therapy…
- Trial name
- Nov IIT- Pyrex (NCT04652258)
- Testing
- Actemra
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- University of Zurich
Melanoma, Non Small Cell Lung Cancer
Dabrafenib and/or Trametinib Rollover Study
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have…
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers
- Trial name
- NCT03340506
- Testing
- dabrafenib, trametinib
- Where
- 38 sites in United States, Argentina and 13 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma
This feasibility study aims to determine if intermittent dosing is deliverable, based on patient and professional willingness to take part in a randomised trial evaluating less rather than the standard durations of treatment.
- Trial name
- INTERIM (NCT03352947)
- Testing
- Dabrafenib, Trametinib
- Where
- United Kingdom
- Volunteers
- 79 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
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
A Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors
BRF112680 is a first-time-in-human study to establish the recommended dose and schedule of the orally administered GSK2118436. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and…
- Trial name
- NCT00880321
- Testing
- GSK2118436, Midazolam
- Where
- 8 sites in United States, Australia
- Volunteers
- 170 people
- Sponsor
- GlaxoSmithKline
BRAF V600E, Colorectal Cancer
A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer
Colorectal cancer (CRC) is the second leading cause of cancer-related death globally. BRAF V600E mutations occur in approximately 12% of metastatic CRC (mCRC) patients, conferring an extremely poor prognosis with a median overall…
- Conditions
- BRAF V600E, Colorectal Cancer, Sintilimab, MSS (Microsatellite Stable)
- Trial name
- NCT07506109
- Testing
- Ipilimumab N01, Sintilimab, Cetuximab
- Where
- 4 sites in China
- Volunteers
- 49 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Malignant Melanoma
Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.
- Trial name
- COMBI-APlus (NCT03551626)
- Testing
- Dabrafenib, Trametinib
- Where
- 100 sites in Argentina, Australia and 21 more
- Volunteers
- 552 people
- Sponsor
- Novartis Pharmaceuticals
Malignant Solid Tumor
A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.
This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts…
- Trial name
- MegaMOST (NCT04116541)
- Testing
- HDM201, Ribociclib, Cabozantinib
- Where
- 13 sites in France
- Volunteers
- 455 people
- Sponsor
- Centre Leon Berard
Hepatic Impairment
Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment
To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with moderate and severe hepatic impairment.
- Trial name
- NCT02873650
- Testing
- dabrafenib
- Where
- 4 sites in United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Melanoma
Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection
This is a prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for Chinese patients with stage III BRAF V600 mutation positive melanoma…
- Trial name
- NCT04666272
- Testing
- dabrafenib, trametinib
- Where
- 8 sites in China
- Volunteers
- 78 people
- Sponsor
- Novartis Pharmaceuticals