34. 神経線維腫症 Neurofibromatosis Clinical trials / Disease details


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

  
19 trials found
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PhaseCountries
1EUCTR2020-005608-20-ES
(EUCTR)
16/02/202219/10/2021Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE)A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) - SPRINKLE Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN)
MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify
Product Name: Selumetinib granules in sprinkle capsules for opening 5 mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Product Name: Selumetinib granules in sprinkle capsules for opening 7.5 mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Trade Name: Koselugo 10mg
Product Name: Selumetinib capsules 10mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Trade Name: Koselugo 25mg
Product Name: Selumetinib capsules 25mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
38Phase 1;Phase 2United States;Spain;Russian Federation;Netherlands;Germany;Italy
2EUCTR2020-005607-39-PL
(EUCTR)
25/01/202214/09/2021Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform NeurofibromasA Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with NF1 who have Symptomatic, Inoperable Plexiforn Neurofibromas (KOMET) - KOMET Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN)
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]
Product Name: Selumetinib 10mg capsule
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Product Name: Selumetinib 25mg capsule
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
146Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Brazil;Australia;Netherlands;Germany;China;Japan
3EUCTR2020-005608-20-NL
(EUCTR)
24/01/202221/10/2021Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE)A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) - SPRINKLE Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN)
MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify
Product Name: Selumetinib granules in sprinkle capsules for opening 5 mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Product Name: Selumetinib granules in sprinkle capsules for opening 7.5 mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Trade Name: Koselugo 10mg
Product Name: Selumetinib capsules 10mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Trade Name: Koselugo 25mg
Product Name: Selumetinib capsules 25mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
38Phase 1;Phase 2United States;Spain;Russian Federation;Germany;Netherlands;Italy
4EUCTR2020-005608-20-DE
(EUCTR)
24/11/202109/09/2021Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE)A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) - SPRINKLE Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN)
MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify
Product Name: Selumetinib granules in sprinkle capsules for opening 5 mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Product Name: Selumetinib granules in sprinkle capsules for opening 7.5 mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Product Name: Selumetinib capsules 10mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Product Name: Selumetinib capsules 25mg
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 1;Phase 2United States;Spain;Russian Federation;Netherlands;Germany;Italy;Japan
5EUCTR2020-005607-39-ES
(EUCTR)
05/10/202123/06/2021Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform NeurofibromasA Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with NF1 who have Symptomatic, Inoperable Plexiforn Neurofibromas (KOMET) - KOMET Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN)
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]
Product Name: Selumetinib 10mg capsule
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Product Name: Selumetinib 25mg capsule
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
146Phase 3United States;Spain;Russian Federation;Italy;France;Canada;Brazil;Poland;Australia;Germany;Netherlands;China;Japan
6EUCTR2020-005607-39-IT
(EUCTR)
08/09/202118/10/2021Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform NeurofibromasA Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with NF1 who have Symptomatic, Inoperable Plexiforn Neurofibromas (KOMET). - KOMET Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN)
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]
Product Name: Selumetinib 25mg capsule
Product Code: [AZD6244]
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Product Name: Selumetinib 10mg capsule
Product Code: [AZD6244]
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
ASTRAZENECA ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
146Phase 3United States;Spain;Russian Federation;Italy;France;Canada;Brazil;Poland;Australia;Germany;Netherlands;China;Japan
7EUCTR2020-005648-52-PL
(EUCTR)
31/05/202126/04/2021Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Toxicity of Selumetinib in Adolescent Children with Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN)A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Toxicity and Pharmacokinetics of Selumetinib after Multiple Doses in Adolescent Children with Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) - Selumetinib Gastrointestinal Toxicity Study (Selumetinib GI Tox Study) Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN)
MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify
Trade Name: Koselugo 10mg
Product Name: Selumetinib 10mg capsule
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
Trade Name: Koselugo 25mg
Product Name: Selumetinib 25mg capsule
Product Code: AZD6244
INN or Proposed INN: Selumetinib
Other descriptive name: selumetinib hyd-sulfate
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1United States;Spain;Poland;Russian Federation
8NCT04166409
(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
9NCT03871257
(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
10NCT03433183
(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;AstraZenecaActive, not recruiting12 YearsN/AAll21Phase 2United States
11EUCTR2017-002635-41-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
12NCT03105258
(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
13NCT02839720
(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
14NCT03109301
(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
15NCT02407405
(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)NULLActive, not recruiting18 YearsN/AAll36Phase 2United States
16NCT02644512
(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
17NCT01362803
(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; Hydrogen Sulfate in Children With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)Neurofibromatosis 1;Neurofibromatosis Type 1;NF1;Neurofibroma, PlexiformDrug: AZD6244National Cancer Institute (NCI)NULLActive, not recruiting2 Years18 YearsAll99Phase 1/Phase 2United States
18NCT00846430
(ClinicalTrials.gov)
October 200816/1/2009Medical Treatment of High-Risk NeurofibromasMedical Treatment of High-Risk Neurofibromas in Patients With Type 1 Neurofibromatosis: A Clinical Trial of Sequential Medical TherapiesNeurofibromatosis 1Drug: Peg-Interferon alpha-2b;Drug: Celecoxib (Celebrex);Drug: Temozolomide (temodar);Drug: Vincristine Sulfate (Oncovin)Spectrum Health HospitalsNULLCompleted2 Years30 YearsAll11Phase 2United States
19NCT00352495
(ClinicalTrials.gov)
June 200613/7/2006Vinblastine and Carboplatin in Treating Young Patients With Newly Diagnosed or Recurrent Low-Grade GliomaA Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade GliomasBrain and Central Nervous System Tumors;Neurofibromatosis Type 1Drug: carboplatin;Drug: vinblastine sulfateChildren's Oncology GroupNational Cancer Institute (NCI)CompletedN/A21 YearsBoth26Phase 1United States;Canada