Actively Recruiting
Study of Cryoablation and Nirogacestat for Desmoid Tumor
Led by Nam Bui · Updated on 2025-09-08
28
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
Sponsors
N
Nam Bui
Lead Sponsor
S
SpringWorks Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary purpose of this protocol is Systemic therapy with oral study agent, nirogacestat, followed by a single cryoablation procedure.
CONDITIONS
Official Title
Study of Cryoablation and Nirogacestat for Desmoid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically-confirmed diagnosis of desmoid tumor that is progressing or symptomatic
- Desmoid tumor is 50 to less than 75% cryoablatable
- Completed any prior desmoid tumor therapy at least 28 days before study treatment, with resolved side effects
- Stable dose of chronic nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 28 days prior to treatment
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening
- Adequate organ and bone marrow function as defined by specific laboratory values
- Negative pregnancy test for women of childbearing potential at screening
- Ability to swallow tablets
- Ability to have MRI
- Willingness and ability to provide written informed consent
- Use of appropriate contraception during treatment and follow-up, with specific requirements for men and women
You will not qualify if you...
- Previous or current treatment with GS inhibitors or anti-Notch antibody therapy
- Current use of desmoid tumor treatments including tyrosine kinase inhibitors, chronic NSAIDs (except stable dose as allowed), or investigational treatments within 28 days before study treatment
- Use of strong or moderate CYP3A4 inhibitors or inducers within 14 days before study treatment
- Known allergy to nirogacestat or its components
- Active or chronic infection at screening
- Malabsorption syndrome or gastrointestinal conditions affecting drug absorption
- History of other high-grade cancers within 2 years, except specific exceptions
- Significant cardiac events or conditions within 6 months prior to consent
- Congenital long QT syndrome or risk factors for Torsades de pointes
- Current or chronic liver disease or biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones)
- Participation in another clinical study with investigational drugs or devices within 28 days before study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94395
Actively Recruiting
Research Team
P
Priyanka Reddy
CONTACT
A
Amir Emami
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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