Selumetinib 10mg capsule ( 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_
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PhaseCountries
1EUCTR2020-005607-39-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
2EUCTR2020-005607-39-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
3EUCTR2020-005607-39-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
4EUCTR2020-005648-52-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