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 (21) 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
Universitätsklinikum Mannheim, Mannheim Cancer Center
RECRUITING
Mannheim
Italy
IRCCS Azienda Ospedaliero-Universitaria S. Orsola
RECRUITING
Bologna
IRCCS Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Fondazione del Piemonte per l'Oncologia Istituto di Candiolo IRCCS
RECRUITING
Candiolo
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS IRST. S.r.l.
RECRUITING
Meldola
Istituto Nazionale Tumori I.R.C.C.S- Fondazione G. Pascale
RECRUITING
Naples
Fondazione Policlinico Unversitario Campus Bio-Medico di Roma
RECRUITING
Roma
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
RECRUITING
Amsterdam
LUMC
RECRUITING
Leiden
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario y Politecnico La Fe
RECRUITING
Valencia
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
The Royal Marsden NHS Foundation Trust
RECRUITING
London
University College London Hospitals NHS Foundation Trust