A Single-Arm, Open-Label Phase 4 Study of Nirogacestat in Adult Premenopausal Females With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Belgium
Cliniques Universitaires Saint-Luc (CUSL)
RECRUITING
Brussels
Germany
Universitaetsmedizin Mannheim
RECRUITING
Mannheim
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
RECRUITING
Bologna
IRCCS Istituto Ortopedico Rizzoli di Bologna
RECRUITING
Bologna
La Fondazione e l'Istituto di Candiolo
RECRUITING
Candiolo
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
RECRUITING
Milan
Istituto Nazionale Tumori I.R.C.C.S- Fondazione G. Pascale
RECRUITING
Naples
Policlinico Universitario Campus Bio-Medico
RECRUITING
Roma
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
RECRUITING
Amsterdam
Academisch Ziekenhuis Leiden
RECRUITING
Leiden
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Institut Catala d'Oncologia
RECRUITING
Barcelona
Hospital Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitari i Politecnic La Fe de Valencia