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Individual Patient Compassionate Use of Nirogacestat

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ClinicalTrials.gov Identifier: NCT05041036
Expanded Access Status : Available
First Posted : September 10, 2021
Last Update Posted : September 10, 2021
Information provided by (Responsible Party):
SpringWorks Therapeutics, Inc.

Tracking Information
First Submitted Date September 7, 2021
First Posted Date September 10, 2021
Last Update Posted Date September 10, 2021
Descriptive Information
Brief Title Individual Patient Compassionate Use of Nirogacestat
Official Title Individual Patient Compassionate Use of Nirogacestat
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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients
  • Desmoid Tumor
  • NOTCH Gene Mutation Positive Tumors
Intervention Drug: Nirogacestat (Gamma Secretase Inhibitor)
Patients will receive nirogacestat tablets to be taken orally.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
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.
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Contact: Sue Scott 203-883-9490 medinfo@springworkstx.com
Contact: Pamela Papino-Wood 203-883-9490 medinfo@springworkstx.com
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT05041036
Other Study ID Numbers NIR-DT-701
Current Responsible Party SpringWorks Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor SpringWorks Therapeutics, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account SpringWorks Therapeutics, Inc.
Verification Date July 2021