Trial name: | Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis |
Agents: | Nirogacestat vs. placebo |
Phase | III |
Status | Closed, active |
Sponsor | SpringWorks Therapeutics, Inc. |
This randomized, double-blind, placebo-controlled, phase 3 trial evaluates nirogacestat versus placebo in the treatment of adult patients with progressing desmoid tumors/aggressive fibromatosis. Further information: https://www.clinicaltrials.gov/ct2/show/study/NCT03785964?term=Nirogacestat&draw=2&rank=1&show_locs=Y#locn
WHO is the trial for? |
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WHAT is the key question that this trial is attempting to answer? |
This study assesses the efficacy, safety and tolerability as well as quality of life (by patient-reported outcomes, PRO) of nirogacestat in patients with a progressing desmoid tumor / aggressive fibromatosis. |
WHY patients might want to participate? |
This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in desmoid tumors/aggressive fibromatosis and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. More about the importance and benefits of joining clinical trials: Please click here. |
WHEN will the trial be open? |
The study is closed, but active |
WHERE is the trial available? |
The trial is being conducted in several study centers in the US, Belgium, Canada and the UK. Further study sites are planned for Germany, the Netherlands and Italy. For further information please check here. Study contact: Nicole H Leedom |
STUDY DESIGN: What does the study look like? |
There are 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Patients in one group will be assigned to nirogacestat, the other group will receive placebo. Nirogacestat will be given at a dosage of 150 mg, taken as a tablet (orally) twice daily. |
HOW do I get more information? |
Patient organisations supporting desmoid (or sarcoma) patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving desmoid, GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein! |
SHARE your experience |
You want to share your experience on this trial? Send us an e-mail to: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein! Note that your experience would be helpful for other patients and patient organisations. |
RESULTS of the study |
No results are available at this time. Future results will be linked here. |
Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.