Selumetinib granule formulation ( 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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agemin
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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
2EUCTR2020-005608-20-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
3NCT05309668
(ClinicalTrials.gov)
January 21, 202226/11/2021Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged =1 to <7 Years With NF1-related Symptomatic, Inoperable PNA 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)Neurofibromatosis Type 1Drug: Selumetinib granule formulation;Drug: Selumetinib capsule formulationAstraZenecaMerck Sharp & Dohme LLCRecruiting1 Year6 YearsAll44Phase 1/Phase 2United States;Italy;Japan;Netherlands;Spain;Germany;Russian Federation
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