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

  
15 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
6EUCTR2020-005648-52-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
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;AstraZenecaActive, not recruiting12 YearsN/AAll21Phase 2United States
8NCT03649165
(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
9NCT03105258
(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
10NCT02839720
(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
11NCT03109301
(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
12NCT02407405
(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
13NCT02644512
(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
14NCT01362803
(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
15NCT01089101
(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 GliomaProcedure: Biospecimen Collection;Drug: SelumetinibNational Cancer Institute (NCI)NULLActive, not recruiting3 Years21 YearsAll220Phase 1/Phase 2United States