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Individual Patient Compassionate Use of Nirogacestat

Primary Purpose

Desmoid Tumor, NOTCH Gene Mutation Positive Tumors

Status

Available

Phase

Locations

Study Type

Expanded Access

Intervention

Nirogacestat (Gamma Secretase Inhibitor)

About this trial

This is an expanded access trial for Desmoid Tumor focused on measuring desmoid tumor, aggressive fibromatosis, desmoid fibromatosis, Notch-positive tumors

Eligibility Criteria

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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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT05041036

First Posted

September 7, 2021

Last Updated

August 30, 2023

Sponsor

SpringWorks Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05041036

Brief Title

Individual Patient Compassionate Use of Nirogacestat

Official Title

Individual Patient Compassionate Use of Nirogacestat

Study Type

Expanded Access

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SpringWorks Therapeutics, Inc.

4. Oversight

5. Study Description

Brief Summary

This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Desmoid Tumor, NOTCH Gene Mutation Positive Tumors

Keywords

desmoid tumor, aggressive fibromatosis, desmoid fibromatosis, Notch-positive tumors

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nirogacestat (Gamma Secretase Inhibitor)

Intervention Description

Patients will receive nirogacestat tablets to be taken orally.

10. Eligibility

Sex

All

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

SpringWorks Medical Information

Phone

(888) 400-7989

medinfo@springworkstx.com

12. IPD Sharing Statement

Learn more about this trial

Individual Patient Compassionate Use of Nirogacestat

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