| Titre |
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF) |
| Protocole ID |
NIR-DT-301 |
| ClinicalTrials.gov ID |
NCT03785964 |
| Type(s) de cancer |
Sarcome |
| Phase |
Phase III |
| Stade |
Sarcome des tissus mous |
| Type étude |
Traitement |
| Médicament |
Nirogacestat |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Thierry Alcindor
|
| Coordonnateur(trice) |
Nathalie Bédard
514-934-1934 poste 64222
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Participant has DT/AF that has progressed by ≥20% as measured by RECIST Version 1.1 Criteria within the 12-month period prior to first dose of study treatment.
- Participant has newly diagnosed, measurably progressing DT/AF that is not amenable to surgical resection or radiation therapy; OR recurrent, progressing DT/AF following CR to initial therapy; OR preexisting DT/AF and has previously received therapy and the residual tumor has progressed.
- Participant agrees to provide archival or new tumor tissue for confirmation of disease.
- If participant was previously treated with an investigational therapy for treatment of DT/AF, participant must have completed prior therapy at least 28 days prior to signing informed consent.
- Participants who are receiving nonsteroidal anti-inflammatory drugs (NSAIDs) as treatment for conditions other than DT/AF.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at screening.
- Participant has adequate organ and bone marrow function.
|
| Critètes d'exclusion |
- Participant has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat.
- Participant has experienced any of the following within 6 months of signing informed consent: clinically significant cardiac disease (New York Heart Association Class III or IV), myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).
- Participant previously received or is currently receiving therapy with GS inhibitors or anti-Notch antibody therapy.
- Participant is currently using or anticipates using a tyrosine kinase inhibitor within 28 days of study treatment.
- Participant is currently using or anticipates using food or drugs that are known strong/moderate cytochrome P450 3A4 (CYP3A4) inhibitors or strong inducers within 14 days prior to the first dose of study treatment.
- Participant is currently using or anticipates using chronic daily NSAIDs for treatment of DT/AF within 28 days of study treatment.
- Participant is unable to tolerate MRI or for whom MRI is contraindicated.
- Participant has experienced other severe acute or chronic medical or psychiatric conditions within 1 year of study start.
|
Groupe d'étude en oncologie du Québec