OncoMatch/Clinical Trials/NCT05949099
Study of Cryoablation and Nirogacestat for Desmoid Tumor
Is NCT05949099 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Nirogacestat for desmoid tumor.
Treatment: Nirogacestat — The primary purpose of this protocol is Systemic therapy with oral study agent, nirogacestat, followed by a single cryoablation procedure.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: gamma secretase inhibitor
Participant previously received or is currently receiving therapy with GS inhibitors or anti-Notch antibody therapy.
Cannot have received: anti-Notch antibody therapy
Participant previously received or is currently receiving therapy with GS inhibitors or anti-Notch antibody therapy.
Cannot have received: tyrosine kinase inhibitor
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.
Cannot have received: NSAID
Exception: chronic non-DT indication, stable dose ≥ 28 days prior to first dose (see inclusion criterion 4)
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.
Cannot have received: investigational treatment
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.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1500 cells/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 × ULN or if creatinine > 1.5 × ULN then calculated creatinine clearance must be ≥ 60 mL/min (using the Cockcroft-Gault formula)
Liver function
Total bilirubin ≤ 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%); AST/ALT ≤ 2 × ULN
Participant has adequate organ and bone marrow function as defined by the following screening laboratory values: Absolute neutrophil count ≥ 1500 cells/μL; Platelets ≥ 100,000μL; Hemoglobin ≥ 9 g/dL; Total bilirubin ≤ 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%); AST/ALT ≤ 2 × ULN; Serum creatinine ≤ 1.5 × ULN or if creatinine > 1.5 × ULN then calculated creatinine clearance must be ≥ 60 mL/min (using the Cockcroft-Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford University · Palo Alto, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05949099 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gamma secretase inhibitor, anti-Notch antibody therapy, tyrosine kinase inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify