Mekinist ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
34神経線維腫症3
280巨大動静脈奇形(頚部顔面又は四肢病変)1

34. 神経線維腫症


臨床試験数 : 133 薬物数 : 186 - (DrugBank : 67) / 標的遺伝子数 : 79 - 標的パスウェイ数 : 190
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03975829
(ClinicalTrials.gov)
November 4, 201930/5/2019Pediatric Long-Term Follow-up and Rollover StudyAn Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)Diffuse Astrocytoma;Anaplastic Astrocytoma;Astrocytoma;Oligodendroglioma, Childhood;Anaplastic Oligodendroglioma;Glioblastoma;Pilocytic Astrocytoma;Giant Cell Astrocytoma;Pleomorphic Xanthoastrocytoma;Anaplastic Pleomorphic Xanthoastrocytoma;Angiocentric Glioma;Chordoid Glioma of Third Ventricle;Gangliocytoma;Ganglioglioma;Anaplastic Ganglioglioma;Dysplastic Gangliocytoma of Cerebrellum;Desmoplastic Infantile Astrocytoma and Ganglioglioma;Papillary Glioneuronal Tumor;Rosette-forming Glioneurona Tumor;Central Neurocytoma;Extraventricular Neurocytoma;Cerebellar Liponeurocytoma;Neurofibromatosis Type 1Drug: dabrafenib;Drug: trametinibNovartis PharmaceuticalsNULLRecruiting1 YearN/AAll250Phase 4United States;Belgium;Canada;Czechia;Denmark;France;Germany;Japan;Netherlands;Russian Federation;Spain;United Kingdom
2EUCTR2019-001317-16-NL
(EUCTR)
30/10/201916/10/2019The TRAIN study: TRAmetinib In Neurofibromatosis type 1 related symptomatic plexiform neurofibromas The TRAIN study: TRAmetinib In Neurofibromatosis type 1 related symptomatic plexiform neurofibromas - TRAIN study: Trametinib in NF1-PNF Adult patients (age >17 years) with (mosaic) NF1 with inoperable symptomatic plexiform neurofibromas
MedDRA version: 20.0;Level: PT;Classification code 10029267;Term: Neurofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MekinistErasmusMCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands
3EUCTR2018-001846-32-SE
(EUCTR)
18/09/201831/07/2018Treatment of symptomatic plexiform neurofibromas, a benign tumour associated with the disorder Neurofibromatosis type 1, in children with the drug trametinibTreatment of NF1-related plexiform neurofibroma with trametinib; a single arm, open-label trial with the goals of volumetric partial remission and pain relief - plexifpc NF1-related plexiform neurofibroma;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Mekinist
Product Name: Mekinist
VO Barnmedicin, Skånes University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 2Sweden

280. 巨大動静脈奇形(頚部顔面又は四肢病変)


臨床試験数 : 27 薬物数 : 30 - (DrugBank : 15) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 153
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003573-26-BE
(EUCTR)
18/12/2019Evaluating the safety and efficacy of Trametinib in Arterio-Venous Malformations that are refractory to standard careMonocentric pilot trial evaluating efficacy of Trametinib in Arteriovenous Malformations that are refractory to standard treatments or for which standard treatment are contra-indicated - TRAMAV Arteriovenous Malformations that are refractory to standard treatments or for which standard treatment are contra-indicated;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Mekinist
Product Name: Mekinist
Cliniques universitaires Saint-LucNULLNAFemale: yes
Male: yes
20Phase 2Belgium