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Looking for participantsPhase4

Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)

Sponsor: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

NCT ID: NCT07176689

View on ClinicalTrials.gov ↗

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).

Desmoid TumorAggressive Fibromatosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

has a negative

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
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)

Where Is This Study? (4 UK sites)

Cambridge University - Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Han Hsi Wong, MDhan.wong@nhs.net

University College London Hospital

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Vasilios Karavasilis, MDvasilios.karavasilis@nhs.net

The Royal Marsden NHS Foundation Trust

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Charlotte Benson, MDcharlotte.benson@rmh.nhs.uk

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Alexander Lee, MDalexander.lee1@nhs.net

How to Get in Touch

US Medical Information

Sponsor contact

CONTACT

888-275-7376 eMediUSA@emdserono.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09