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Individual Patient Compassionate Use of Nirogacestat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05041036
Expanded Access Status : Available
First Posted : September 10, 2021
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
SpringWorks Therapeutics, Inc.

Study Description
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Brief Summary:
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee, and applicable competent authority approval.

Condition or disease Intervention/treatment
Desmoid Tumor NOTCH Gene Mutation Positive Tumors Drug: Nirogacestat (Gamma Secretase Inhibitor)

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Individual Patient Compassionate Use of Nirogacestat

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Nirogacestat (Gamma Secretase Inhibitor)
    Patients will receive nirogacestat tablets to be taken orally.
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patient has a serious, debilitating or life-threatening medical condition that cannot be treated satisfactorily with an authorized medicinal product or other available standard treatment options, or all other treatment options have been exhausted.
  • Patient does not qualify to participate in an ongoing clinical trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041036


Contacts
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Contact: SpringWorks Medical Information (888) 400-7989 medinfo@springworkstx.com

Sponsors and Collaborators
SpringWorks Therapeutics, Inc.
More Information
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Responsible Party: SpringWorks Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05041036    
Other Study ID Numbers: NIR-DT-701
First Posted: September 10, 2021    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Keywords provided by SpringWorks Therapeutics, Inc.:
desmoid tumor
aggressive fibromatosis
desmoid fibromatosis
Notch-positive tumors
Additional relevant MeSH terms:
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Neoplasms
Fibromatosis, Aggressive
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Gamma Secretase Inhibitors and Modulators
Nirogacestat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action