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Clinical trials for Dabrafenib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    41 result(s) found for: Dabrafenib. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2016-002794-35 Sponsor Protocol Number: CPDR001F2301 Start Date*: 2017-02-20
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, double-blind, placebo-controlled, phase III study comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated pati...
    Medical condition: Unresectable or metastatic BRAF V600 mutant melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) AT (Completed) CZ (Completed) PL (Completed) BG (Completed) GR (Completed) BE (Completed) PT (Completed) NL (Completed) DK (Completed) HU (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-001499-12 Sponsor Protocol Number: BRF116013 Start Date*: 2013-04-22
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects with Advanced BRAF ...
    Medical condition: Advanced BRAF V600-Mutation Positive Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10049280 Solid tumour LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) Outside EU/EEA ES (Completed) DE (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002577-18 Sponsor Protocol Number: APR-633 Start Date*: 2017-12-13
    Sponsor Name:APREA THERAPEUTICS AB
    Full Title: A phase I/IIa study to investigate the safety and clinical activity of APR-246 in combination with dabrafenib in patients with BRAF V600 mutant unresectable metastatic melanoma resistant to dabrafe...
    Medical condition: BRAF V600 Mutant Metastatic Melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004015-20 Sponsor Protocol Number: CDRB436G2201 Start Date*: 2018-01-09
    Sponsor Name:Novartis Pharma AG
    Full Title: Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or...
    Medical condition: Paediatric patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065443 Malignant glioma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) CZ (Completed) DE (Completed) ES (Ongoing) IT (Completed) FI (Completed) DK (Completed) FR (Completed) NL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2011-006088-23 Sponsor Protocol Number: MEK116513 Start Date*: 2012-06-20
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase III, randomised, open-label study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to the BRAF inhibitor vemurafenib in subjects with unresectab...
    Medical condition: Metastatic melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) BE (Completed) AT (Completed) NO (Completed) IE (Completed) CZ (Completed) ES (Completed) NL (Completed) HU (Completed) FI (Completed) IT (Completed) PL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-000087-30 Sponsor Protocol Number: Swecranio1-21 Start Date*: 2021-07-06
    Sponsor Name:Skane University Hospital, Dept of Endocrinology
    Full Title: Neoadjuvant and postoperative treatment with dabrafenib and trametinib for papillary craniopharyngioma
    Medical condition: Papillary craniopharyngioma
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004864 10084813 Papillary craniopharyngioma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004459-19 Sponsor Protocol Number: CDRB436G2401 Start Date*: 2019-07-31
    Sponsor Name:Novartis Farmacéutica S.A.
    Full Title: An open label, multi-center roll-over study to assess long-term effect in pediatric patients treated with Tafinlar (dabrafenib) and/or Mekinist (trametinib)
    Medical condition: Children and Adolescents with Cancers Harboring V600 mutations
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) SE (Trial now transitioned) DE (Trial now transitioned) CZ (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) NL (Trial now transitioned) DK (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-001266-15 Sponsor Protocol Number: BRF115532 Start Date*: 2013-02-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: COMBI-AD: A phase III randomized double blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 muta...
    Medical condition: High-risk BRAF V600 mutation-positive melanoma after surgical resection.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10027156 Skin melanomas (excl ocular) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SE (Completed) CZ (Completed) DE (Completed) NO (Completed) GB (Completed) AT (Completed) GR (Completed) IT (Completed) NL (Completed) DK (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2011-006087-49 Sponsor Protocol Number: MEK115306 Start Date*: 2012-04-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to dabrafenib and placebo as first-line therapy in subjec...
    Medical condition: Cutaneous melanoma - aggressive form of skin cancers.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10040808 Skin cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) ES (Completed) GB (Completed) NL (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-003596-35 Sponsor Protocol Number: MEK116540 Start Date*: 2015-12-15
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescents Subj...
    Medical condition: Children and Adolescents with Cancers Harboring V600 mutations
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-004760-21 Sponsor Protocol Number: BIO-TAILOR Start Date*: 2020-10-07
    Sponsor Name:FONDAZIONE MELANOMA ONLUS
    Full Title: Dabrafenib and trametinib in circulating free DNA BRAFV600 mutated metastatic melanoma patients: a prospective phase II, open label, multicentre study – (Bioliquid TAILOR study – BIO-TAILOR)
    Medical condition: Metastatic melanoma patients with tissue BRAFWT signature and a molecular shift to circulating free DNA BRAF mutated positive melanomas upon progression to an anti PD-1 therapy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-002615-15 Sponsor Protocol Number: BGBIL006 Start Date*: 2016-12-14
    Sponsor Name:Helse Bergen HF, Haukeland universitetssjukehus
    Full Title: A Phase Ib/II randomised open label study of BGB324 in combination with pembrolizumab or dabrafenib/trametinib compared to pembrolizumab or dabrafenib/trametinib alone, in patients with advanced no...
    Medical condition: Advanced non-resectable (Stage IIIc) or metastatic (Stage IV) melanoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10053571 Melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000168-27 Sponsor Protocol Number: CDRB436F2410 Start Date*: 2018-09-19
    Sponsor Name:Novartis Pharma AG
    Full Title: COMBI-APlus: Open-label, phase IIIb study of dabrafenib in COMBInation with trametinib in the Adjuvant treatment of stage III BRAF V600 mutation-positive melanoma after complete resection to evalua...
    Medical condition: Stage III BRAF V600 mutation-positive melanoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025650 Malignant melanoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) FI (Completed) GB (GB - no longer in EU/EEA) LT (Completed) GR (Completed) SI (Completed) SK (Completed) BE (Completed) LV (Completed) HU (Completed) PT (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-004577-12 Sponsor Protocol Number: BRF116613 Start Date*: 2015-03-23
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: Phase II biomarker study evaluating the upfront combination of BRAF inhibitor dabrafenib with MEK inhibitor trametinib versus the combination after eight weeks of monotherapy with dabrafenib or tra...
    Medical condition: patients with metastatic and unresectable stage III or IV melanoma harbouring an activating BRAF mutation
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10027156 Skin melanomas (excl ocular) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-004966-33 Sponsor Protocol Number: UZB-2013-001 Start Date*: 2014-04-30
    Sponsor Name:UZ Brussel
    Full Title: A phase II clinical trial on the combination of dabrafenib and trametinib for BRAF-inhibitor pretreated patients with advanced BRAF V600 mutant melanoma
    Medical condition: advanced BRAF V600 mutant melanoma
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027156 Skin melanomas (excl ocular) HLT
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066600 Melanoma recurrent PT
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027480 Metastatic malignant melanoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000681-55 Sponsor Protocol Number: 3475-022 Start Date*: 2015-10-06
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase I/II Study to Assess the Safety and Efficacy of MK-3475 in Combination with Trametinib and Dabrafenib in Subjects with Advanced Melanoma
    Medical condition: advanced or metastatic melanoma - all parts of the trial advanced (unresectable and/or metastatic) solid tumours - Parts 4 and 5
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    21.1 100000004864 10053571 Melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000742-21 Sponsor Protocol Number: 2017/2527 Start Date*: 2017-07-31
    Sponsor Name:Gustave Roussy
    Full Title: Efficacy of a selective MEK (trametinib) and BRAFV600E (dabrafenib) inhibitors associated with radioactive iodine (RAI) for the treatment of refractory metastatic differentiated thyroid cancer with...
    Medical condition: Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients with RAS or BRAF mutation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10016935 Follicular thyroid cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066474 Thyroid cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033701 Papillary thyroid cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002941-49 Sponsor Protocol Number: ERRITI Start Date*: 2017-01-31
    Sponsor Name:University Hospital Essen (Anstalt des öffentlichen Rechts)
    Full Title: Enhancing Radioiodine Incorporation into Radio Iodine Refractory Thyroid Cancers with MAPK Inhibition: A single center pilot study
    Medical condition: Radio Iodine Refractory Thyroid Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001705-87 Sponsor Protocol Number: BRF117019 Start Date*: 2014-03-06
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Phase II, Open-label, Study in Subjects with BRAF V600E Mutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and ...
    Medical condition: Mutations of BRAF V600E have been identified at a high frequency in melanoma, PTC, colorectal and ovarian cancers. Such mutations have also been reported in some rare cancers such as anaplastic t...
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) SE (Completed) BE (Completed) AT (Completed) DK (Completed) NL (Completed) ES (Ongoing) NO (Completed)
    Trial results: View results
    EudraCT Number: 2015-003120-31 Sponsor Protocol Number: N15IMP Start Date*: 2015-12-03
    Sponsor Name:Antoni van leeuwenhoek ziekenhuis
    Full Title: Phase 2 Study Comparing Pembrolizumab with Intermittent/Short-term Dual MAPK Pathway Inhibition Plus Pembrolizumab in patients harboring the BRAFV600 mutation (IMPemBra)
    Medical condition: Irresectable stage III and stage IV melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
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