BridgeMD
An Open-label, Phase 4 Study of Nirogacestat in Adult Premenopausal Females with Desmoid Tumor/Aggressive Fibromatosis (DT/AF).
EU CTIS ID: 2024-515215-21-00
What this study is testing
To determine the ovarian function recovery rate of ovarian toxicity (OT) treatment emergent adverse events (TEAEs).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1.Participant must be female, postpubertal aged ≥18 and ≤40 years of age at the time of signing the informed consent and premenopausal at baseline.
- 2.Participant is eligible to participate if she is not pregnant or breastfeeding, and the following conditions apply: - Is of childbearing potential but is abstinent or using at least 1 highly effective contraceptive method. - The participant has not harvested or donated eggs for the purpose of reproduction for at least 90 days prior to the first dose of nirogacestat and agrees to not harvest or donate eggs for the purpose of reproduction during the Treatment and Clinical Follow-up Periods.
- 3.Participant has histologically confirmed DT/AF with symptomatic or progressive disease requiring systemic treatment.
- 4.Participants who have received prior chemotherapy or radiation must meet the definition of premenopausal ≥2 weeks after the end of the final cycle of chemotherapy or final radiation treatment. Participants who have received prior gonadotoxic chemotherapy or pelvic radiotherapy are not eligible for this study.
- 5.Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at screening.
- 6.Participant has adequate organ and bone marrow function.
You likely can't join if
- 1.Participant has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat.
- 10.Participant is currently enrolled or was enrolled within 28 days of first dose of study treatment in another clinical study with any investigational drug or device. Participationin observational studies may be permitted with prior approval from the medical monitor/sponsor.
- 11.Participant has a history of heavy tobacco smoking (defined as ≥20 pack years) and/or is a current smoker (>1 pack per day) at the time of informed consent.
- 12.Participant has experienced other severe acute or chronic medical or psychiatric conditions, including recent or active suicidal ideation or behavior, or a laboratory abnormality that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- 13.Participant has known hypersensitivity to the active substance or to any of the excipients of nirogacestat.
- 14.Participant is unable to comply with study-related procedures including, but not limited to the following: the completion of a menstrual diary and electronic patient-reported outcomes and the ability to return to the clinic for hormone level blood draws timed to the menstrual cycle (Day 1-5) at the required visits.
See the full eligibility criteria
Who can join
- 1.Participant must be female, postpubertal aged ≥18 and ≤40 years of age at the time of signing the informed consent and premenopausal at baseline.
- 2.Participant is eligible to participate if she is not pregnant or breastfeeding, and the following conditions apply: - Is of childbearing potential but is abstinent or using at least 1 highly effective contraceptive method. - The participant has not harvested or donated eggs for the purpose of reproduction for at least 90 days prior to the first dose of nirogacestat and agrees to not harvest or donate eggs for the purpose of reproduction during the Treatment and Clinical Follow-up Periods.
- 3.Participant has histologically confirmed DT/AF with symptomatic or progressive disease requiring systemic treatment.
- 4.Participants who have received prior chemotherapy or radiation must meet the definition of premenopausal ≥2 weeks after the end of the final cycle of chemotherapy or final radiation treatment. Participants who have received prior gonadotoxic chemotherapy or pelvic radiotherapy are not eligible for this study.
- 5.Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at screening.
- 6.Participant has adequate organ and bone marrow function.
- 7.Participant can swallow tablets and has no gastrointestinal conditions affecting absorption.
- 8.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
What rules you out
- 1.Participant has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat.
- 10.Participant is currently enrolled or was enrolled within 28 days of first dose of study treatment in another clinical study with any investigational drug or device. Participationin observational studies may be permitted with prior approval from the medical monitor/sponsor.
- 11.Participant has a history of heavy tobacco smoking (defined as ≥20 pack years) and/or is a current smoker (>1 pack per day) at the time of informed consent.
- 12.Participant has experienced other severe acute or chronic medical or psychiatric conditions, including recent or active suicidal ideation or behavior, or a laboratory abnormality that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- 13.Participant has known hypersensitivity to the active substance or to any of the excipients of nirogacestat.
- 14.Participant is unable to comply with study-related procedures including, but not limited to the following: the completion of a menstrual diary and electronic patient-reported outcomes and the ability to return to the clinic for hormone level blood draws timed to the menstrual cycle (Day 1-5) at the required visits.
- 2.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 -Symptomatic pulmonary embolism
- 3.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 with no evidence of metastatic disease for 3 years at the time of informed consent.
- 4.Participant has known severe hepatic impairment.
- 5.Participant previously received or is currently receiving therapy with gamma secretase (GS) inhibitors or anti-Notch antibody therapy.
- 6.Participant is currently using any treatment for DT/AF including tyrosine kinase inhibitors (TKIs) or any investigational treatment within 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study treatment. All toxicities from prior therapy must be resolved to Grade ≤1 or clinical baseline prior to the first dose of study treatment.
- 7.Participant is currently using or anticipates using food or drugs that are known strong or moderate cytochrome P450 (CYP) 3A4 inhibitors or strong or moderate CYP3A inducers within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment.
- 8.Participants 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.
- 9.Participant is currently using or has used hormonal contraception or ovarian suppression within 90 days prior to the first dose of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- 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, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. 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 EU CTIS; the study team decides eligibility.