Studies
| Study First Submitted Date | 2021-08-24 |
| Study First Posted Date | 2021-08-31 |
| Last Update Posted Date | 2021-08-31 |
| Verification Month Year | July 2021 |
| Verification Date | 2021-07-31 |
| Last Update Posted Date | 2021-08-31 |
Conditions
| Sequence: | 52268903 | Sequence: | 52268904 | Sequence: | 52268905 |
| Name | Neurofibromatosis Type 1-Associated Plexiform Neurofibromas | Name | Histiocytic Neoplasm | Name | Other MAP-K Pathway Driven Diseases |
| Downcase Name | neurofibromatosis type 1-associated plexiform neurofibromas | Downcase Name | histiocytic neoplasm | Downcase Name | other map-k pathway driven diseases |
Id Information
| Sequence: | 40229579 |
| Id Source | org_study_id |
| Id Value | MEK-NF1-701 |
Interventions
| Sequence: | 52581462 |
| Intervention Type | Drug |
| Name | Mirdametinib (MEK Inhibitor) |
| Description | Patients will receive oral mirdametinib. |
Keywords
| Sequence: | 80007632 | Sequence: | 80007633 | Sequence: | 80007634 | Sequence: | 80007635 | Sequence: | 80007636 |
| Name | RASopathies | Name | NF1 | Name | Neurofibromatosis | Name | Plexiform Neurofibromas | Name | Langerhans |
| Downcase Name | rasopathies | Downcase Name | nf1 | Downcase Name | neurofibromatosis | Downcase Name | plexiform neurofibromas | Downcase Name | langerhans |
Browse Conditions
| Sequence: | 193860301 | Sequence: | 193860284 | Sequence: | 193860285 | Sequence: | 193860286 | Sequence: | 193860287 | Sequence: | 193860288 | Sequence: | 193860289 | Sequence: | 193860290 | Sequence: | 193860291 | Sequence: | 193860292 | Sequence: | 193860293 | Sequence: | 193860294 | Sequence: | 193860295 | Sequence: | 193860296 | Sequence: | 193860297 | Sequence: | 193860298 | Sequence: | 193860299 | Sequence: | 193860300 |
| Mesh Term | Nervous System Neoplasms | Mesh Term | Neurofibromatoses | Mesh Term | Neurofibromatosis 1 | Mesh Term | Neurofibroma | Mesh Term | Neurofibroma, Plexiform | Mesh Term | Nerve Sheath Neoplasms | Mesh Term | Neoplasms, Nerve Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplastic Syndromes, Hereditary | Mesh Term | Neurocutaneous Syndromes | Mesh Term | Nervous System Diseases | Mesh Term | Heredodegenerative Disorders, Nervous System | Mesh Term | Neurodegenerative Diseases | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Peripheral Nervous System Diseases | Mesh Term | Neuromuscular Diseases | Mesh Term | Peripheral Nervous System Neoplasms |
| Downcase Mesh Term | nervous system neoplasms | Downcase Mesh Term | neurofibromatoses | Downcase Mesh Term | neurofibromatosis 1 | Downcase Mesh Term | neurofibroma | Downcase Mesh Term | neurofibroma, plexiform | Downcase Mesh Term | nerve sheath neoplasms | Downcase Mesh Term | neoplasms, nerve tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplastic syndromes, hereditary | Downcase Mesh Term | neurocutaneous syndromes | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | heredodegenerative disorders, nervous system | Downcase Mesh Term | neurodegenerative diseases | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | peripheral nervous system diseases | Downcase Mesh Term | neuromuscular diseases | Downcase Mesh Term | peripheral nervous system neoplasms |
| Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48410632 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | SpringWorks Therapeutics, Inc. |
Central Contacts
| Sequence: | 12032052 | Sequence: | 12032053 |
| Contact Type | primary | Contact Type | backup |
| Name | Sue Scott | Name | Pamela Papino-Wood |
| Phone | 203-883-9490 | Phone | 203-883-9490 |
| medinfo@springworkstx.com | medinfo@springworkstx.com | ||
| Role | Contact | Role | Contact |
Eligibilities
| Sequence: | 30822198 |
| Gender | All |
| Minimum Age | 2 Years |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria: Patient has a serious, debilitating or life-threatening medical condition with no suitable treatment available, has exhausted current standard of care or declined medically appropriate treatment for ethical or medical reasons. Patient does not qualify to participate in any ongoing clinical trial sponsored by SpringWorks in an accessible geographical location. |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254112271 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 2 |
| Minimum Age Unit | Years |
Responsible Parties
| Sequence: | 28934543 |
| Responsible Party Type | Sponsor |