Clinical Trials in Italy / NCT07176689
Recruiting
Phase 4
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
NCT07176689 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Desmoid TumorAggressive Fibromatosis
Study summary
This study is being conducted to study how nirogacestat may affect the ovarian function of adult premenopausal women with progressing desmoid tumors/aggressive fibromatosis.
Eligibility
Inclusion Criteria:
* Participant is female, postpubertal aged ≥18 and ≤40 years of age at the time of signing the informed consent and premenopausal at baseline. Premenopausal is defined as meeting all of the following: Estradiol \>30 pg/mL. Follicle-stimulating hormone (FSH) \<40 IU/L. Regular menses (e.g., menstrual cycle length of 21 to 35 days) for at least 3 menstrual cycles prior to signing informed consent
* Participant uses 1 highly effective non-hormonal contraceptive method, has a negative pregnancy test prior to first dose of study treatment), is not breastfeeding, agrees to not harvest or donate eggs for at least 90 days prior to and during the study
* Participant has histologically confirmed DT/AF with symptomatic or progressive disease requiring systemic treatment
* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at screening
* Participant has adequate organ and bone marrow function.
Exclusion Criteria:
* 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.
* Participant has had lymphoma, leukemia, or any malignancy within the past 5 years at the time of informed consent, except for any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast), with no evidence of metastatic disease for 3 years at the time of informed consent.
* Participant has known hepatic impairment
* Participant previously received or is currently receiving gamma secretase inhibitors or anti-Notch antibody therapy
* Participant is currently using any treatment for DT/AF including tyrosine kinase inhibitors (TKIs) or any investigational treatment 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study treatment
* Participant is currently using or anticipates using food or drugs that are known strong/moderate cytochrome P450 (CYP) 3A4 inhibitors, or strong CYP3A inducers within 14 days prior to the first dose of study treatment.
* Participant has a history of polycystic ovary syndrome, hypothalamic amenorrhea, severe endometriosis involving ovaries, family history of primary ovarian insufficiency, any chromosomal abnormality, mutation, gene variant or medical condition associated with early/premature menopause, including a history of OT while on a TKI
* Participant is currently using or has used hormonal contraception or ovarian suppression within 90 days prior to first dose of study treatment
* Participant has a history of heavy tobacco smoking (≥20 pack years) or is a current smoker (\>1 pack per day)
* Participant has experienced other severe acute or chronic medical or psychiatric conditions within 1 year of signing informed consent.
* Participant is unable to comply with study related procedures (including, but not limited to, the completion of a menstrual diary and electronic patient-reported outcomes and ability to return to clinic for hormone level blood draws timed to the menstrual cycle (days 1-5)
Primary outcome measure(s)
- Ovarian function recovery rate of ovarian toxicity (OT) treatment-emergent adverse events (TEAEs) — Up to 24 cycles (each cycle is 28 days) of treatment and up to 2 years in the Clinical Follow-up Period
Ovarian function recovery is defined as achieving the resumption of ≥2 consecutive menstrual periods and an FSH level \<30 mIU/mL with concomitant estradiol \<80 pg/mL OR resumption of ≥2 consecutive menstrual periods and AMH level within normal range adjusted for age and pretreatment baseline OR a positive serum β-HCG pregnancy test.
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| Cliniques Universitaires Saint-Luc (CUSL) | Brussels | Belgium | Recruiting |
| Universitaetsmedizin Mannheim | Mannheim | Germany | Recruiting |
| IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l. | Meldola | Forli-Cesena | Recruiting |
| La Fondazione e l'Istituto di Candiolo | Candiolo | Torino | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola | Bologna | Italy | Recruiting |
| IRCCS Istituto Ortopedico Rizzoli di Bologna | Bologna | Italy | Recruiting |
| Fondazione IRCCS Istituto Nazionale dei Tumori Milano | Milan | Italy | Recruiting |
| Istituto Nazionale Tumori I.R.C.C.S- Fondazione G. Pascale | Naples | Italy | Recruiting |
| Policlinico Universitario Campus Bio-Medico | Roma | Italy | Recruiting |
| Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL) | Amsterdam | Netherlands | Recruiting |
| Academisch Ziekenhuis Leiden | Leiden | Netherlands | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
| Institut Catala d'Oncologia | Barcelona | Spain | Recruiting |
| Hospital General Universitario Gregorio Maranon | Madrid | Spain | Recruiting |
| Hospital Fundacion Jimenez Diaz | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | Spain | Recruiting |
| Hospital Universitario Miguel Servet | Zaragoza | Spain | Recruiting |
| Cambridge University - Addenbrooke's Hospital | Cambridge | United Kingdom | Recruiting |
| University College London Hospital | London | United Kingdom | Recruiting |
| The Royal Marsden NHS Foundation Trust | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust | Manchester | United Kingdom | Recruiting |
Other trials for the same condition
A Study of AL102 in Patients With Progressing Desmoid Tumors
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07176689 on ClinicalTrials.gov ↗ ← All trials in Italy