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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
Status

 

NIR-DT-301 - A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Closed to enrollment

More information

NIR-DT-301 - A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Go to Health Care Provider version

DiagnosisDesmoid Tumor, Aggressive FibromatosisStudy StatusClosed to enrollment
PhaseIII
Age18 Years and olderRandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: Nirogacestat 150 mg by mouth, twice daily
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT03785964
International Sponsor
SpringWorks Therapeutics, Inc.
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre
McGill University Health Centre
Centres
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A

 

 

Study Description

This research looks at how well a medicine called nirogacestat works in treating desmoid tumours or aggressive fibromatosis. At first, patients participating in the study are split into two groups randomly: one group gets nirogacestat, and the other group gets a placebo, which is a which is a substance that has no therapeutic effect and is indistinguishable from the actual drug. This part of the study is "double-blind," meaning neither the participants nor the researchers know who's getting the real medicine and who's getting the placebo. Later, when participants move to the next part of the study, called the "open-label phase," everyone gets nirogacestat. 

Inclusion Criteria
  • Participants must be 18 years or older
  • Must have confirmed Desmoid Tumor or Aggressive Fibromatosis that has progressed or not responded after at least one line of therapy 
  • Participants must be up and about at least 50% of their daily waking hours
  • Participants must meet organ function and lab criteria prior to starting on study
  • Participants must sign an informed consent and agree to the study assessments and requirements

Other inclusion and exclusion criteria may apply and will be discussed with you by your study team.