Selumetinib Sulfate ( DrugBank: Selumetinib, Sulfate )

1 disease
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4

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
1NCT04166409
(ClinicalTrials.gov)		January 3, 202015/11/2019A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade GliomaA Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)Low Grade Astrocytoma;Low Grade Glioma;Metastatic Low Grade Astrocytoma;Metastatic Low Grade GliomaProcedure: Biospecimen Collection;Drug: Carboplatin;Procedure: Magnetic Resonance Imaging;Other: Quality-of-Life Assessment;Other: Questionnaire Administration;Drug: Selumetinib Sulfate;Drug: Vincristine SulfateNational Cancer Institute (NCI)NULLRecruiting2 Years21 YearsAll220Phase 3United States;Canada;Puerto Rico
2NCT03871257
(ClinicalTrials.gov)		October 4, 201911/3/2019A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade GliomaA Phase 3 Randomized Study of Selumetinib Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)Low Grade Glioma;Neurofibromatosis Type 1;Visual Pathway GliomaDrug: Carboplatin;Procedure: Magnetic Resonance Imaging;Other: Quality-of-Life Assessment;Other: Questionnaire Administration;Drug: Selumetinib Sulfate;Drug: Vincristine SulfateNational Cancer Institute (NCI)NULLRecruiting2 Years21 YearsAll290Phase 3United States;Canada;Puerto Rico
3EUCTR2017-002635-41-GB
(EUCTR)		26/09/201819/06/2019 A PAEDIATRIC PHASE I/II STUDY OF INTERMITTENT DOSING OF THE MEK-1 INHIBITOR SELUMETINIB IN CHILDREN WITH NEUROFIBROMATOSIS TYPE-1 AND INOPERABLE PLEXIFORM NEUROFIBROMA AND/OR PROGRESSIVE OPTIC PATHWAY GLIOMAA paediatric phase I/II study of intermittent dosing of the MEK-1 inhibitor selumetinib in children with neurofibromatosis type-1 and inoperable plexiform neurofibroma and/or progressive optic pathway glaiom - Intermittent Selumetinib dosing Phase I/II study Childhood NF1 tumours Neurofibromatosis type 1 associated plexiform neurofibromas Neurofibromatosis type 1 associated progressive or relapsed optic pathway glioma
MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850
MedDRA version: 20.0;Classification code 10065866;Term: Plexiform neurofibroma;System Organ Class: 100000004864
MedDRA version: 20.0;Classification code 10030935;Term: Optic nerve glioma;System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Product Name: Selumetinib
INN or Proposed INN: selumetinib sulfate
Other descriptive name: Selumetinib Hyd-sulphate		Great Ormond Street HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		38 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
4NCT02839720
(ClinicalTrials.gov)		April 11, 201720/7/2016Selumetinib in Treating Patients With Neurofibromatosis Type 1 and Cutaneous NeurofibromaPilot Study of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) for Adults With Neurofibromatosis Type 1 (NF1) and Cutaneous Neurofibromas (CNF)Cutaneous Neurofibroma;Neurofibromatosis Type 1;Optic Nerve GliomaOther: Laboratory Biomarker Analysis;Drug: Selumetinib SulfateNational Cancer Institute (NCI)NULLActive, not recruiting18 YearsN/AAll24Phase 2United States