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Individual Patient Compassionate Use of Nirogacestat

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
Email medinfo@springworkstx.com Email 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