OncoMatch/Clinical Trials/NCT05949099
Study of Cryoablation and Nirogacestat for Desmoid Tumor
Is NCT05949099 recruiting? Yes, currently enrolling (May 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
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
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