34. 神経線維腫症 Neurofibromatosis Clinical trials / Disease details
臨床試験数 : 137 / 薬物数 : 213 - (DrugBank : 76) / 標的遺伝子数 : 87 - 標的パスウェイ数 : 200
Showing 1 to 10 of 137 diseases
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-005608-20-ES (EUCTR) | 16/02/2022 | 19/10/2021 | Pharmacokinetics, 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) Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to ... | 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 A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and ... | 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 NeurofibromatosisType 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;C ... | 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 Product Name: Selumetinibgranules in sprinkle capsules for opening 5 mg Product Code: AZD6244 INN or P ... | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 38 | Phase 1;Phase 2 | United States;Spain;Russian Federation;Netherlands;Germany;Italy | ||
| 2 | EUCTR2020-005608-20-NL (EUCTR) | 24/01/2022 | 21/10/2021 | Pharmacokinetics, 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) Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to ... | 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 A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and ... | 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 NeurofibromatosisType 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;C ... | 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 Product Name: Selumetinibgranules in sprinkle capsules for opening 5 mg Product Code: AZD6244 INN or P ... | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 38 | Phase 1;Phase 2 | United States;Spain;Russian Federation;Germany;Netherlands;Italy | ||
| 3 | NCT04544007 (ClinicalTrials.gov) | December 15, 2021 | 2/9/2020 | A Phase II Trial of Poly-ICLC for Low-Grade Gliomas | A Phase II Trial of Poly-ICLC for Progressive, Previously Treated Low-Grade Gliomas in Children and Young Adults With Neurofibromatosis Type 1 A Phase II Trial of Poly-ICLC for Progressive, Previously Treated Low-Grade Gliomas in Children and ... | NF1;Low-grade Glioma | Drug: Poly ICLC | University of Alabama at Birmingham | Children's Healthcare of Atlanta;Children's Hospital Los Angeles | Not yet recruiting | N/A | 22 Years | All | 20 | Phase 2 | United States |
| 4 | NCT05130866 (ClinicalTrials.gov) | December 1, 2021 | 10/11/2021 | Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas Efficacy and Safety of REC-2282 in Patients With Progressive NeurofibromatosisType 2 (NF2) Mutated M ... | A Parallel-group, Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants With Progressive NF2 Mutated Meningiomas A Parallel-group, Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and ... | Neurofibromatosis Type 2 | Drug: REC-2282;Drug: Placebo | Recursion Pharmaceuticals Inc. | NULL | Not yet recruiting | 12 Years | N/A | All | 89 | Phase 2/Phase 3 | NULL |
| 5 | NCT04750928 (ClinicalTrials.gov) | November 29, 2021 | 10/2/2021 | Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I(NF1) Related Aty ... | A Phase I/II Study of the Cyclin-Dependent Kinase(CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type 1 (NF1) Related Atypical Neurofibromas A Phase I/II Study of the Cyclin-Dependent Kinase(CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosi ... | Neurofibromatosis 1 | Drug: Abemaciclib | National Cancer Institute (NCI) | NULL | Recruiting | 12 Years | N/A | All | 50 | Phase 1/Phase 2 | United States |
| 6 | EUCTR2020-005608-20-DE (EUCTR) | 24/11/2021 | 09/09/2021 | Pharmacokinetics, 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) Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to ... | 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 A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and ... | 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 NeurofibromatosisType 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;C ... | 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 Product Name: Selumetinibgranules in sprinkle capsules for opening 5 mg Product Code: AZD6244 INN or P ... | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 38 | Phase 1;Phase 2 | United States;Spain;Russian Federation;Netherlands;Germany;Italy | ||
| 7 | NCT04924608 (ClinicalTrials.gov) | November 19, 2021 | 14/5/2021 | Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas Efficacy and Safety of Selumetinib in Adults With NF1Who Have Symptomatic, Inoperable Plexiform Neur ... | A 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 Plexiform Neurofibromas (KOMET) A Phase III, Multicentre, International Study With a Parallel, Randomised, Double-blind, Placebo-con ... | Neurofibromatosis 1;Plexiform Neurofibroma (PN) | Drug: Selumetinib;Other: Placebo | AstraZeneca | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 146 | Phase 3 | United States;Australia;Brazil;Canada;China;France;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;United Kingdom United States;Australia;Brazil;Canada;China;France;Germany;Italy;Japan;Netherlands;Russian Federatio ... |
| 8 | JPRN-jRCT2041210036 | 19/10/2021 | 24/06/2021 | A 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 Plexiform Neurofibromas A Phase III, Multicentre, International Study With a Parallel, Randomised, Double-blind, Placebo-con ... | A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas. - KOMET A global study to demonstrate the effectiveness of selumetinib in participants with NF1who have symp ... | Neurofibromatosis 1, Plexiform Neurofibroma (PN) | Arm A: selumetinib 25 mg/m2 orally bid Arm B: placebo orally bid | Yamaji Shigeyuki | NULL | Pending | >= 18age old | Not applicable | Both | 15 | Phase 3 | Australia;Brasil;Canada;China;France;Germany;Italy;Netherland;Poland;Russia;Spain;USA;UK;Japan |
| 9 | EUCTR2020-005607-39-ES (EUCTR) | 05/10/2021 | 23/06/2021 | Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas Efficacy and Safety of Selumetinib in Adults with NF1who have Symptomatic, Inoperable Plexiform Neur ... | A 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 A Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo-con ... | 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] NeurofibromatosisType 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN) MedDRA versi ... | 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 Product Name: Selumetinib10mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other desc ... | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 146 | Phase 3 | United States;Spain;Russian Federation;Italy;France;Canada;Brazil;Poland;Australia;Germany;Netherlands;China;Japan United States;Spain;Russian Federation;Italy;France;Canada;Brazil;Poland;Australia;Germany;Netherlan ... | ||
| 10 | NCT05028166 (ClinicalTrials.gov) | October 1, 2021 | 24/8/2021 | Individual Patient Compassionate Use of Mirdametinib | Neurofibromatosis Type 1-Associated Plexiform Neurofibromas;Histiocytic Neoplasm;Other MAP-K Pathway Driven Diseases NeurofibromatosisType 1-Associated Plexiform Neurofibromas;Histiocytic Neoplasm;Other MAP-K Pathway ... | Drug: Mirdametinib (MEK Inhibitor) | SpringWorks Therapeutics, Inc. | NULL | Available | 2 Years | N/A | All | NULL |