NCT05949099

Study of Cryoablation and Nirogacestat for Desmoid Tumor

Phase II Study of Cryoablation and Nirogacestat for Desmoid Tumor

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Nam Bui · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this protocol is Systemic therapy with oral study agent, nirogacestat, followed by a single cryoablation procedure.

Detailed description

The primary purpose of this protocol is treatment. Systemic therapy with oral study agent, nirogacestat, will be given for 3 cycles (1 cycle = 28 days) followed by a single cryoablation procedure between Cycles 3 and 4, and then continued nirogacestat for Cycles 4 through 26. Treatment with nirogacestat may continue via this study for up to 24 months (26 cycles of treatment), unless there is progression of disease, intolerance, subject withdraws their consent, start of a new anticancer therapy, or until Subject Study Completion or Termination occurs.

Conditions

• Desmoid Tumor

Interventions

Type	Name	Description
DRUG	Nirogacestat	Nirogacestat 150 mg by mouth twice-daily continuously for Cycles 1 through 3. Treatment with nirogacestat may continue via this study protocol for up to 24 months (26 cycles of treatment), unless there is progression of disease, intolerance, start of new anticancer therapy, or Subject Study Completion or Termination occurs.
PROCEDURE	Cryoablation	Cryoablation procedure (single session) of one tumor mass between Cycles 3 and 4 of nirogacestat treatment

Timeline

• Start date: 2023-08-15
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2023-07-17
• Last updated: 2025-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study