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Study of Cryoablation and Nirogacestat for Desmoid Tumor

NCT05949099 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-09-08

No results posted yet for this study

Summary

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

Conditions

  • Desmoid Tumor

Interventions

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

Sponsors & Collaborators

  • SpringWorks Therapeutics, Inc.

    collaborator INDUSTRY

  • Nam Bui

    lead OTHER

Principal Investigators

  • Nam Bui, M.D. · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2028-02-01
Completion
2028-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05949099 on ClinicalTrials.gov