Selumetinib    (DrugBank: Selumetinib)

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19

34. 神経線維腫症 [臨床試験数:120,薬物数:182(DrugBank:72),標的遺伝子数:84,標的パスウェイ数:194
Searched query = "Neurofibromatosis", "NF1", "von Recklinghausen disease", "NF2"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
19 / 120 trials found
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1NCT04590235
(ClinicalTrials.gov)
November 12, 202028/7/2020A Study of Selumetinib in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)A Phase 1 Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Selumetinib, a Selective Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor, in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)Neurofibromatosis 1;Neurofibroma PlexiformDrug: SelumetinibAstraZenecaMerck Sharp & Dohme Corp.Not yet recruiting3 Years99 YearsAll32Phase 1China
2ChiCTR2000036770
2020-10-012020-08-25Establishment of prediction model of selumetinib therapy in the treatment of plexiform neurofibroma based on exosomes test from liquid biopsyEstablishment of prediction model of selumetinib therapy in the treatment of plexiform neurofibroma based on exosomes test from liquid biopsy Plexiform Neurofibromatosis type 1Gold Standard:Clinical outcomes;Index test:Prediction model of selumetinib therapy in the treatment of plexiform neurofibroma based on exosomes test from liquid biopsy;Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineNULLPending265BothTarget condition:32;Difficult condition:0China
3JPRN-JapicCTI-205422
01/9/202020/08/2020A Phase 1 Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Selumetinib, a Selective Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor, in Japanese Paediatric Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable and Symptomatic Plexiform Neurofibromas (PN)A Phase 1 Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Selumetinib, a Selective Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor, in Japanese Paediatric Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable and Symptomatic Plexiform Neurofibromas (PN) Neurofibromatosis Type 1 and Inoperable and Symptomatic Plexiform NeurofibromaIntervention name : Selumetinib
INN of the intervention : -
Dosage And administration of the intervention : Selumetinib 25 mg/m2 BID
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
AstraZeneca KKNULLrecruiting318BOTH9Phase 1Japan, North America
4NCT04495127
(ClinicalTrials.gov)
August 31, 202029/7/2020Selumetinib Paediatric NF1 Japan StudyA Phase 1 Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Selumetinib, a Selective Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor, in Japanese Paediatric Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable and Symptomatic Plexiform Neurofibromas (PN)Neurofibromatosis Type 1Drug: SelumetinibAstraZenecaNULLRecruiting3 Years18 YearsAll12Phase 1Japan
5NCT04166409
(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)Astrocytoma;Low Grade GliomaDrug: Carboplatin;Other: Quality-of-Life Assessment;Other: Questionnaire Administration;Drug: Selumetinib Sulfate;Drug: Vincristine SulfateNational Cancer Institute (NCI)NULLRecruiting2 Years21 YearsAll200Phase 3United States;Canada
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
6NCT03871257
(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;Other: Quality-of-Life Assessment;Other: Questionnaire Administration;Drug: Selumetinib Sulfate;Drug: Vincristine SulfateNational Cancer Institute (NCI)NULLRecruiting2 Years21 YearsAll290Phase 3United States;Canada
7NCT03433183
(ClinicalTrials.gov)
October 2, 201929/1/2018SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath TumorsSARC031: A Phase 2 Trial of the MEK Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Combination With the mTOR Inhibitor Sirolimus for Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath TumorsMalignant Peripheral Nerve Sheath Tumors;Neurofibromatosis 1Drug: Selumetinib;Drug: SirolimusSarcoma Alliance for Research through CollaborationUnited States Department of Defense;AstraZenecaRecruiting12 YearsN/AAll21Phase 2United States
8NCT03326388
(ClinicalTrials.gov)
September 26, 20198/9/2017Intermittent Dosing Of Selumetinib In Childhood NF1 Associated TumoursA 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 GliomaNeurofibromatosis Type 1;Plexiform Neurofibroma;Optic Nerve GliomaDrug: SelumetinibGreat Ormond Street Hospital for Children NHS Foundation TrustAstraZenecaRecruiting3 Years18 YearsAll30Phase 1;Phase 2United Kingdom
9EUCTR2017-002635-41-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]
Great Ormond Street HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
38Phase 1;Phase 2United Kingdom
10NCT03649165
(ClinicalTrials.gov)
September 5, 201824/8/2018A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male ParticipantsA Phase I, Open-label, Single-center Relative Bioavailability and Food Effect Randomized Crossover Study of New Granule and Capsule Formulations of Selumetinib (AZD6244) in Healthy Male SubjectsNeurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs);Healthy ParticipantsDrug: Treatment A;Drug: Treatment B;Drug: Treatment C;Drug: Treatment D;Drug: AcetaminophenAstraZenecaNULLCompleted18 Years45 YearsMale24Phase 1United States
No.TrialIDDate_
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11NCT03259633
(ClinicalTrials.gov)
October 30, 201721/8/2017An Intermediate Access Protocol for Selumetinib for Treatment of Neurofibromatosis Type 1An Intermediate Access Protocol for Selumetinib for Treatment of Neurofibromatosis Type 1 With Inoperable, Progressive/Symptomatic Plexiform Neurofibromas (PN)NF type1 With Inoperable Plexiform NeurofibromasDrug: SelumetinibAstraZenecaNULLApproved for marketing2 Years130 YearsAllUnited States
12NCT03095248
(ClinicalTrials.gov)
May 8, 20178/3/2017Trial of Selumetinib in Patients With Neurofibromatosis Type II Related TumorsPhase 2 Trial of Selumetinib in Patients With Neurofibromatosis Type II Related TumorsNeurofibromatosis 2;Vestibular Schwannoma;Meningioma;Ependymoma;GliomaDrug: SelumetinibChildren's Hospital Medical Center, CincinnatiAstraZenecaRecruiting3 Years45 YearsAll34Phase 2United States
13NCT03105258
(ClinicalTrials.gov)
May 1, 201723/3/2017Selumetinib Pilot Study for Cutaneous NeurofibromasPilot Study of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) for Adults With Neurofibromatosis Type 1 (NF1) and Cutaneous Neurofibromas (cNF)Neurofibromatosis Type 1;Cutaneous NeurofibromaDrug: SelumetinibUniversity of Alabama at BirminghamNational Cancer Institute (NCI)Not yet recruiting18 YearsN/AAll24Phase 2United States
14NCT02839720
(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;Drug: Selumetinib SulfateNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll24Phase 2United States
15NCT03109301
(ClinicalTrials.gov)
April 7, 201711/4/2017Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in People With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST)A Phase II Trial of the Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Patients With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST)Neoplasms, Nerve Tissue;Neurofibromatosis 1;Heredodegenerative Disorders, Nervous System;Peripheral Nervous System DiseasesDrug: Selumetinib (AZD6244 hyd sulfate) 50mg/dose;Drug: Selumetinib (AZD6244 hyd sulfate) 25mg/m2National Cancer Institute (NCI)NULLWithdrawn3 Years99 YearsAll0Phase 2United States
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
16NCT02407405
(ClinicalTrials.gov)
January 7, 20162/4/2015MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform NeurofibromasPhase II Trial of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform NeurofibromasNeurofibromatosis 1 (NF1);Plexiform Neurofibromas (PN)Drug: SelumetinibNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll60Phase 2United States
17NCT02644512
(ClinicalTrials.gov)
December 201531/12/2015MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform NeurofibromasPhase II Trial of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform NeurofibromasNeurofibromatosis 1;Plexiform NeurofibromasDrug: SelumetinibNational Cancer Institute (NCI)NULLRecruiting18 Years99 YearsBoth50Phase 2United States
18NCT01362803
(ClinicalTrials.gov)
September 21, 201127/5/2011AZD6244 Hydrogen Sulfate for Children With Nervous System TumorsA Phase I/II Study of the Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor Selumetinib (AZD6244; HYD Sulfate) in Children With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)Neurofibromatosis 1;Neurofibromatosis Type 1;NF 1;Neurofibroma, PlexiformDrug: AZD6244National Cancer Institute (NCI)NULLActive, not recruiting2 Years18 YearsAll99Phase 1;Phase 2United States
19NCT01089101
(ClinicalTrials.gov)
April 19, 201017/3/2010Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade GliomaA Phase 1 and Phase II and Re-Treatment Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade GliomaLow Grade Glioma;Recurrent Childhood Pilocytic Astrocytoma;Recurrent Neurofibromatosis Type 1;Recurrent Visual Pathway Glioma;Refractory Neurofibromatosis Type 1;Refractory Visual Pathway GliomaOther: Laboratory Biomarker Analysis;Other: Pharmacological Study;Drug: SelumetinibNational Cancer Institute (NCI)NULLRecruiting3 Years21 YearsAll220Phase 1;Phase 2United States