Actively Recruiting
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
Led by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany · Updated on 2026-05-08
50
Participants Needed
21
Research Sites
292 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is being conducted to study how nirogacestat may affect the ovarian function of adult premenopausal women with progressing desmoid tumors/aggressive fibromatosis.
CONDITIONS
Official Title
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, postpubertal, aged 18 to 40 years at consent and premenopausal at baseline, defined by estradiol >30 pg/mL, FSH <40 IU/L, and regular menses for at least 3 cycles
- Uses one highly effective non-hormonal contraceptive method
- Negative pregnancy test before first dose
- Not breastfeeding and agrees not to harvest or donate eggs for at least 90 days before and during the study
- Histologically confirmed desmoid tumor/aggressive fibromatosis with symptomatic or progressive disease needing systemic treatment
- ECOG performance status ≤2 at screening
- Adequate organ and bone marrow function
You will not qualify if you...
- Known malabsorption syndrome or gastrointestinal conditions impairing nirogacestat absorption
- Significant cardiac disease or events within 6 months prior to consent
- History of lymphoma, leukemia, or malignancy within 5 years except certain treated localized cancers without metastasis for 3 years
- Known hepatic impairment
- Previous or current use of gamma secretase inhibitors or anti-Notch antibody therapy
- Current use of tyrosine kinase inhibitors or investigational treatments for desmoid tumor within 28 days prior to first dose
- Use or anticipated use of strong/moderate CYP3A4 inhibitors or inducers within 14 days prior to first dose
- History of polycystic ovary syndrome, hypothalamic amenorrhea, severe ovarian endometriosis, family history of primary ovarian insufficiency, chromosomal abnormalities, or medical conditions linked to early menopause
- Use of hormonal contraception or ovarian suppression within 90 days prior to first dose
- Heavy tobacco smoking history (≥20 pack years) or current smoker (>1 pack/day)
- Severe acute or chronic medical or psychiatric conditions within 1 year prior to consent
- Inability to comply with study procedures including completing menstrual diary, electronic patient-reported outcomes, and timely clinic visits for hormone level tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Cliniques Universitaires Saint-Luc (CUSL)
Brussels, Belgium, 1200
Actively Recruiting
2
Universitätsklinikum Mannheim, Mannheim Cancer Center
Mannheim, Germany, 68167
Actively Recruiting
3
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS IRST. S.r.l.
Meldola, Forli-Cesena, Italy, 47104
Actively Recruiting
4
Fondazione del Piemonte per l'Oncologia Istituto di Candiolo IRCCS
Candiolo, Torino, Italy, 10060
Actively Recruiting
5
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
6
IRCCS Azienda Ospedaliero-Universitaria S. Orsola
Bologna, Italy, 40138
Actively Recruiting
7
Istituto Nazionale Tumori I.R.C.C.S- Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
8
Fondazione Policlinico Unversitario Campus Bio-Medico di Roma
Roma, Italy, 00128
Actively Recruiting
9
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
10
LUMC
Leiden, Netherlands, 2333 ZA
Actively Recruiting
11
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
12
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
13
Hospital Universitario Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
14
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28041
Actively Recruiting
15
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
16
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
17
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
18
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
19
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
20
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
21
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
U
US Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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