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Official title Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study
ClinicalTrials.gov ID: NCT05879146
What this study is testing
What is Nirogacestat?
Nirogacestat is an investigational medicine, being studied as a potential treatment for tumor.
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
- To learn about the safety and effects of an investigational drug called nirogacestat when given to participants with a desmoid tumor/aggressive fibromatosis
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- This study will enroll approximately 40 participants diagnosed with DT. Participants must meet the following eligibility criteria to be enrolled:
- Age ≥ 18 years. Individuals younger than 18 years old are excluded. More than 99% of the population evaluated at MDACC with a diagnosis of DT is...
- Histologically documented DT with evidence of radiographic tumor progression (≥ 10% or absolute increase in dimensions of ≥ 10 mm in maximal...
- Recurrent or primary disease
- Symptomatic disease or impending morbidity (as defined by physician) and patient and physician agree treatment would be of benefit
You likely can't join if
- Participants are excluded from this study if any of the following criteria apply:
- Unable to undergo serial biopsies
- Participants with familial adenomatous polyposis
- Unable to tolerate MRI or for whom MRI is contraindicated
- Pregnant or breastfeeding women are excluded from this study. Based on findings in animal studies, oral administration of nirogacestat to pregnant...
- Known hypersensitivity to nirogacestat or any of its excipients
See the full eligibility criteria
Who can join
- This study will enroll approximately 40 participants diagnosed with DT. Participants must meet the following eligibility criteria to be enrolled:
- Age ≥ 18 years. Individuals younger than 18 years old are excluded. More than 99% of the population evaluated at MDACC with a diagnosis of DT is older than 18. Sixty-three percent of the population with a diagnosis of...
- Histologically documented DT with evidence of radiographic tumor progression (≥ 10% or absolute increase in dimensions of ≥ 10 mm in maximal diameter) in unidimensional measurement within the previous 18 months...
- Recurrent or primary disease
- Symptomatic disease or impending morbidity (as defined by physician) and patient and physician agree treatment would be of benefit
- Treatment naïve or progression on or after any prior therapy for DT. Participant must have discontinued prior therapy for at least 28 days or 5 half-lives of the drug, whichever is greater. All toxicities from prior...
- Able to tolerate radiographic progression (up to 20% increase in tumor longest diameter) as determined by treating oncologist based on morbidity and tumor growth is not threatening vital structures
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Are appropriate for systemic therapy
- Have accessible tumors for serial biopsies
- Agree to provide new tumor tissue. Tumor tissue from the archival (tumor bank) may be used if the biopsy is performed after discontinuation of prior therapy and the participant must have discontinued prior therapy for...
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Adequate organ and bone marrow function as defined by the following screening laboratory values:
- Absolute neutrophil count ≥ 1500 cells/μL;
- Platelets ≥ 100,000 μL;
- Hemoglobin ≥ 9 g/dL;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (isolated bilirubin \> 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%);
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase)/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase) ≤ 2 × ULN; and
- If Creatinine \> 1.5 x ULN then calculated creatinine clearance must be . 60 mL/min (using the Cockcroft-Gault formula).
- Can swallow tablets and have no gastrointestinal conditions affecting absorption
- Agree to the use of adequate contraception during the treatment period and for at least 4 months for men and women after the last dose of the study treatment (see Appendix 1 for more information)
- Have the ability to understand and the willingness to sign a written informed consent document
- English and non-English speaking patients
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Participants with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
What rules you out
- Participants are excluded from this study if any of the following criteria apply:
- Unable to undergo serial biopsies
- Participants with familial adenomatous polyposis
- Unable to tolerate MRI or for whom MRI is contraindicated
- Pregnant or breastfeeding women are excluded from this study. Based on findings in animal studies, oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in embryo-fetal...
- Known hypersensitivity to nirogacestat or any of its excipients
- Participants requiring the use of any excluded concomitant medications listed in Table 2 during the course of the study
- Unable to comply with study-related procedures in the opinion of the investigator
- Patients with cognitive impairment requiring a legally authorized representative for consent
- Patients with uncontrolled intercurrent illness (Indicate clearly what type or extent)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with positive viral load will be excluded
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia
- Patients who are receiving any other investigational agents
- Patients with an additional malignancy and brain metastases. There is not enough evidence of the effects of nirogacestat in other malignancies at this time
- Participant has experienced any of the following within 6 months of signing informed consent: 15.1 clinically significant cardiac disease (New York Heart Association Class III or IV); 15.2 myocardial infarction; 15.3...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.