34. Neurofibromatosis Clinical trials / Disease details
Clinical trials : 133 / Drugs : 186 - (DrugBank : 67) / Drug target genes : 79 - Drug target pathways : 190
Showing 1 to 10 of 30 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 | JPRN-jRCT2041210036 | 01/07/2022 | 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 selumetinibin participants with NF1 who have symp ... | Neurofibromatosis 1, Plexiform Neurofibroma (PN) | Arm A: selumetinib 25 mg/m2 orally bid Arm B: placebo orally bid | Sato Katsuyuki | NULL | Recruiting | >= 18age old | Not applicable | Both | 15 | Phase 3 | Australia;Brasil;Canada;China;France;Germany;Italy;Poland;Russia;Spain;USA;UK;Japan |
| 2 | 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 SelumetinibGranule 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 Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT; ... | 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 | ||
| 3 | EUCTR2020-005607-39-PL (EUCTR) | 25/01/2022 | 14/09/2021 | Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas Efficacy and Safety of Selumetinibin Adults with NF1 who 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] Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN) MedDRA vers ... | 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;United Kingdom;Italy;France;Canada;Poland;Brazil;Australia;Netherlands;Germany;China;Japan United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Brazil;Australia;Ne ... | ||
| 4 | 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 SelumetinibGranule 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 Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT; ... | 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 | ||
| 5 | NCT05309668 (ClinicalTrials.gov) | January 21, 2022 | 26/11/2021 | Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged =1 to <7 Years With NF1-related Symptomatic, Inoperable PN Pharmacokinetics, Safety and Efficacy of the SelumetinibGranule 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) A Phase I/II, Single-Arm, Open Label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and ... | Neurofibromatosis Type 1 | Drug: Selumetinib granule formulation;Drug: Selumetinib capsule formulation | AstraZeneca | Merck Sharp & Dohme LLC | Recruiting | 1 Year | 6 Years | All | 44 | Phase 1/Phase 2 | United States;Italy;Japan;Netherlands;Spain;Germany;Russian Federation |
| 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 SelumetinibGranule 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 Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT; ... | 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 | 44 | Phase 1;Phase 2 | United States;Spain;Russian Federation;Netherlands;Germany;Italy;Japan | ||
| 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 Selumetinibin Adults With NF1 Who 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 LLC | Recruiting | 18 Years | N/A | All | 146 | Phase 3 | United States;Australia;Brazil;Canada;China;France;Germany;Italy;Japan;Poland;Russian Federation;Spain;United Kingdom;Netherlands United States;Australia;Brazil;Canada;China;France;Germany;Italy;Japan;Poland;Russian Federation;Spa ... |
| 8 | 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 Selumetinibin Adults with NF1 who 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] Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN) MedDRA vers ... | 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 | Not Recruiting | 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 ... | ||
| 9 | EUCTR2020-005607-39-IT (EUCTR) | 08/09/2021 | 18/10/2021 | Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas Efficacy and Safety of Selumetinibin Adults with NF1 who 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] Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN) MedDRA vers ... | 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 Product Name: Selumetinib25mg capsule Product Code: [AZD6244] INN or Proposed INN: Selumetinib Other de ... | 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 | NCT05101148 (ClinicalTrials.gov) | July 21, 2021 | 16/6/2021 | Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Tolerability of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Tolerability of Selumetini ... | A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Tolerability and Pharmacokinetics of Selumetinib After Multiple Doses in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Toler ... | Neurofibromatosis Type 1 | Drug: Selumetinib | AstraZeneca | Merck Sharp & Dohme LLC | Active, not recruiting | 12 Years | 17 Years | All | 24 | Phase 1 | United States;Poland;Russian Federation;Spain |