Nirogacestat in Premenopausal Females With Desmoid Tumor/​Aggressive Fibromatosis

Agents: Nirogacestat (Ogsiveo)
Phase IV
Status Recruiting
Sponsor SpringWorks Therapeutics

 

For further information please also consult https://clinicaltrials.gov/study/NCT07176689

A Single-Arm, Open-Label Phase 4 Study of Nirogacestat (Ogsiveo®) in Adult Premenopausal Females With Desmoid Tumors/Aggressive Fibromatosis (DT/AF).

This study is being conducted to study how nirogacestat may affect the ovarian function of adult premenopausal women with progressing DT/AF.

WHO is the trial for?
  • 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 ECOG performance status ≤2 at screening

WHAT is the key question that this trial is attempting to answer?

 How may nirogacestat affect the ovarian function of adult premenopausal women with progressing desmoid tumors/aggressive fibromatosis?

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy.

This trial will further support the research in desmoid tumors/aggressive fibromatosis and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

More about the importance and benefits of joining clinical trials: Please click here.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is currently being conducted in UK, London. More study sites to be opened in January 2026 in Spain, Italy, Belgium, Netherlands, and Germany.

For further information check here Study Details | NCT07176689 | Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF) | ClinicalTrials.gov

Study Contact:

Name: Nicole H Leedom
Phone Number: 984-204-8065
Email: clinical@springworkstx.com

STUDY DESIGN: What does the study look like?

 This study is not blinded. All patients receive the same treatment: Nirogacestat 150 mg orally, twice daily.

Time frame: Up to 24 cycles (each cycle is 28 days) of treatment and up to 2 years in the Clinical Follow-up Period

HOW do I get more information?

 Patient organisations supporting desmoid (or sarcoma) patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients. If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

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