Study of Cryoablation and Nirogacestat for Desmoid Tumor
ConditionDesmoid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNam Bui
About this trial
The primary purpose of this protocol is Systemic therapy with oral study agent, nirogacestat, followed by a single cryoablation procedure.
Eligibility criteria
Qualifiers
Histologically-confirmed diagnosis of desmoid tumor (DT) that is progressing (by RECIST criteria over the past 12 months) or symptomatic (as defined by change in pain regimen or impairment of activities of daily living (ADLs), or at investigator discretion). Note: Must have diagnosis of desmoid tumor on pathology report.
Desmoid tumor is 50 to <75% cryoablatable.
Proximity (< 1 cm) to critical structures, such as nerves, vessels, bowel, or skin, at risk of injury during ablation, despite hydrodissection
Large size ( > 100 mL)
Disqualifiers
Participant previously received or is currently receiving therapy with GS inhibitors or anti-Notch antibody therapy.
Participant is currently using any treatment for DT including tyrosine kinase inhibitors (TKIs), NSAIDS (chronic daily use - except as in inclusion criterion 4) 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 or moderate cytochrome P450 3A4 (CYP3A4) inhibitors, or strong CYP3a inducers within 14 days prior to the first dose of study treatment.
Participant has known hypersensitivity to the active substance or to any of the excipients of nirogacestat.
Trial design
Treatments tested in this trial
- Nirogacestat
- Cryoablation
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov