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Nirogacestat for Aggressive Fibromatosis (DeFi Trial)
DeFi Trial Summary
This trial will evaluate if nirogacestat is effective in treating desmoid tumor/aggressive fibromatosis. Half the participants will receive nirogacestat, the other half placebo, in the double-blind phase. All participants will receive nirogacestat in the open-label phase.
DeFi Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DeFi Trial Design
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Who is running the clinical trial?
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- You are taking medication for deep vein thrombosis or atrial fibrillation, such as tyrosine kinase inhibitors or NSAIDs, or are currently in a clinical trial for these conditions. You must stop taking these medications for at least 28 days before starting the study treatment.You have had serious medical or mental health issues in the past year.You cannot have an MRI for medical reasons or because you cannot tolerate it.
- Group 1: Double-Blind Phase - Placebo
- Group 2: Double-Blind Phase - Nirogacestat
- Group 3: Open-Label Phase - Nirogacestat
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you please provide more information on the risks associated with Nirogacestat oral tablet?
"Given that this is a Phase 3 trial with evidence of efficacy and safety from multiple rounds of data, our team at Power rates the Nirogacestat oral tablet a 3 for safety."
In how many medical facilities is this clinical trial being conducted?
"Currently, this clinical trial has 36 patients enrolled. A few notable locations where patients are receiving treatment are DUMC/Duke Cancer Center in Durham, Henry-Joyce Cancer Clinic in Nashville, and UT Southwestern Medical Center in Dallas."
Is Nirogacestat oral tablet a new medication?
"First studied in 2013 at the National Institutes of Health Clinical Center, Nirogacestat has had 169 completed clinical trials as of now. Out of the 8 clinical trials that are presently active, a majority of them are based in Durham, North carolina."
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