Studies
| Study First Submitted Date | 2021-09-07 |
| Study First Posted Date | 2021-09-10 |
| Last Update Posted Date | 2021-09-10 |
| Verification Month Year | July 2021 |
| Verification Date | 2021-07-31 |
| Last Update Posted Date | 2021-09-10 |
Browse Interventions
| Sequence: | 96207609 | Sequence: | 96207610 | Sequence: | 96207611 | Sequence: | 96207612 |
| Mesh Term | Gamma Secretase Inhibitors and Modulators | Mesh Term | Nirogacestat | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
| Downcase Mesh Term | gamma secretase inhibitors and modulators | Downcase Mesh Term | nirogacestat | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52269013 | Sequence: | 52269014 |
| Name | Desmoid Tumor | Name | NOTCH Gene Mutation Positive Tumors |
| Downcase Name | desmoid tumor | Downcase Name | notch gene mutation positive tumors |
Id Information
| Sequence: | 40229640 |
| Id Source | org_study_id |
| Id Value | NIR-DT-701 |
Interventions
| Sequence: | 52581559 |
| Intervention Type | Drug |
| Name | Nirogacestat (Gamma Secretase Inhibitor) |
| Description | Patients will receive nirogacestat tablets to be taken orally. |
Keywords
| Sequence: | 80007775 | Sequence: | 80007776 | Sequence: | 80007777 | Sequence: | 80007778 |
| Name | desmoid tumor | Name | aggressive fibromatosis | Name | desmoid fibromatosis | Name | Notch-positive tumors |
| Downcase Name | desmoid tumor | Downcase Name | aggressive fibromatosis | Downcase Name | desmoid fibromatosis | Downcase Name | notch-positive tumors |
Browse Conditions
| Sequence: | 193860605 | Sequence: | 193860606 | Sequence: | 193860607 | Sequence: | 193860608 | Sequence: | 193860609 | Sequence: | 193860610 | Sequence: | 193860611 |
| Mesh Term | Neoplasms | Mesh Term | Fibromatosis, Aggressive | Mesh Term | Fibroma | Mesh Term | Neoplasms, Fibrous Tissue | Mesh Term | Neoplasms, Connective Tissue | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type |
| Downcase Mesh Term | neoplasms | Downcase Mesh Term | fibromatosis, aggressive | Downcase Mesh Term | fibroma | Downcase Mesh Term | neoplasms, fibrous tissue | Downcase Mesh Term | neoplasms, connective tissue | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type |
| 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 |
Sponsors
| Sequence: | 48410717 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | SpringWorks Therapeutics, Inc. |
Central Contacts
| Sequence: | 12032071 | Sequence: | 12032072 |
| 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: | 30822255 |
| Gender | All |
| Minimum Age | N/A |
| 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: | 254060798 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
Responsible Parties
| Sequence: | 28934600 |
| Responsible Party Type | Sponsor |