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| Diagnosis | Desmoid Tumor, Aggressive Fibromatosis | Study Status | Closed to enrollment |
| Phase | III |
| Age | 18 Years and older | Randomisation | YES |
| Line of treatment | First line treatment, Disease relapse or progression |
| Routes of Treatment Administration | Drug: Nirogacestat 150 mg by mouth, twice daily |
| Last Posted Update | 2024-04-09 |
| ClinicalTrials.gov # | NCT03785964 |
International Sponsor
SpringWorks Therapeutics, Inc.Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre
McGill University Health Centre Centres
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.
