At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Nirogacestat (drug)
- How long the study runs
- Study runs about 65 months (dates as stated)
- About the drug or intervention
- Nirogacestat — drug: Nirogacestat oral tablet
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 40 Years
- Who
- Female
- Number of participants
- 50
- Started
- 2025-09-17
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for desmoid tumor
- • Phase4 - 50 participants
- • This study is being conducted to study how nirogacestat may affect the ovarian function of adult premenopausal women with progressing desmoid tumors/aggressive fibromatosis
Who can take part?
- • Ages 18 Years to 40 Years
- • Diagnosed with desmoid tumor
- • Female only
Where?
- • Cambridge - Cambridge University - Addenbrooke's Hospital
- • London - University College London Hospital
- • London - The Royal Marsden NHS Foundation Trust
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is being conducted to study how nirogacestat may affect the ovarian function of adult premenopausal women with progressing desmoid tumors/aggressive fibromatosis.
More detail
Desmoid tumors, also referred to as aggressive fibromatosis, are rare, locally invasive, slow growing soft tissue tumors. Although considered benign because of their inability to metastasize, desmoid tumors can cause significant morbidity and occasionally mortality in patients. Nirogacestat is a tumor inhibitor that works by slowing or stopping the growth of tumor cells. Nirogacestat is a tablet taken by mouth and has been approved in the USA for adult patients with progressing desmoid tumors who require systemic treatment. This is an open-label study to characterize the incidence and ovarian function recovery rates of ovarian toxicity (OT) events and to evaluate the efficacy, safety, and tolerability of nirogacestat in postpubertal and premenopausal females with desmoid tumors (DT).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 40 Years
- Who can join: Female only
Biomarkers mentioned
What the study is looking for
- ✓Participant has confirmed by a biopsy DT/AF with causing symptoms or progressive disease requiring systemic treatment
- ✓Participant has an activity scale (ECOG) performance status ≤2 at screening
- ✓Participant has adequate organ and bone marrow function.
Who cannot take part
- ✗Participant has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption...
- ✗Participant has known liver impairment
- ✗Participant previously received or is currently receiving gamma secretase inhibitors or anti-Notch antibody therapy
- ✗Participant is currently using or has used hormonal contraception or ovarian suppression within 90 days prior to...
- ✗Participant has a history of heavy tobacco smoking (≥20 pack years) or is a current smoker (\>1 pack per day)
See the full criteria
Where Is This Study? (4 UK sites)
Cambridge University - Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
University College London Hospital
London NW1 2PG, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
US Medical Information
Sponsor contactCONTACT
