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New treatment option for Desmoid Tumor
Official title Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
ClinicalTrials.gov ID: NCT07176689
What this study is testing
What is Nirogacestat?
Nirogacestat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for desmoid tumor.
Also referred to as PF-03084014, Ogsiveo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being conducted to study how nirogacestat may affect the ovarian function of adult premenopausal women with progressing desmoid tumors/aggressive fibromatosis.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- Participant is female, postpubertal aged ≥18 and ≤40 years of age at the time of signing the informed consent and premenopausal at baseline...
- Participant uses 1 highly effective non-hormonal contraceptive method, has a negative pregnancy test prior to first dose of study treatment), is not...
- 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.
You likely can't join if
- 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...
- Participant has had lymphoma, leukemia, or any malignancy within the past 5 years at the time of informed consent, except for any locally recurring...
- 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...
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Mannheim, Germany
- Meldola, Forli-Cesena, Italy
- Candiolo, Torino, Italy
- Bologna, Italy
- Milan, Italy
- Naples, Italy
- Roma, Italy
- Amsterdam, Netherlands
- Leiden, Netherlands
- Barcelona, Spain
- Madrid, Spain
- Valencia, Spain
- Zaragoza, Spain
- Cambridge, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Mannheim, Germany; Meldola, Forli-Cesena, Italy; Candiolo, Torino, Italy; Bologna, Italy; Milan, Italy and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.