Actively Recruiting
Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study
Led by M.D. Anderson Cancer Center · Updated on 2026-04-13
40
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
SpringWorks Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn about the safety and effects of an investigational drug called nirogacestat when given to participants with a desmoid tumor/aggressive fibromatosis
CONDITIONS
Official Title
Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed desmoid tumor with measurable disease showing tumor growth of at least 10% or 10 mm increase in the last 18 months
- Recurrent or primary desmoid tumor disease
- Symptomatic or risk of morbidity with agreement between patient and physician that treatment is beneficial
- Treatment-naive or progressed after prior therapy, with at least 28 days since last treatment and resolved toxicities to Grade 1 or baseline
- Able to tolerate up to 20% tumor growth without threat to vital organs
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Suitable for systemic therapy
- Tumors accessible for repeated biopsies
- Agree to provide new tumor tissue or archival tissue obtained after prior therapy discontinuation
- Undetectable hepatitis B viral load if chronic HBV infection and on therapy
- Treated and cured hepatitis C infection or undetectable viral load if currently treated
- Adequate organ and bone marrow function based on blood tests
- Able to swallow tablets with no digestive conditions affecting absorption
- Agree to use effective contraception during and for 4 months after treatment
- Able to understand and willing to sign informed consent
- English or non-English speaking
- Prior or concurrent cancer allowed if it does not interfere with study assessments
- Cardiac function assessed as New York Heart Association Class 2B or better
You will not qualify if you...
- Unable to undergo repeated tumor biopsies
- Have familial adenomatous polyposis
- Unable to have or contraindicated for MRI
- Pregnant or breastfeeding
- Known allergy to nirogacestat or its ingredients
- Require prohibited medications during the study
- Unable to comply with study procedures
- Cognitive impairment requiring legal representative consent
- Uncontrolled illness
- HIV infection with detectable viral load despite therapy
- Psychiatric or social conditions limiting study compliance
- Unresolved toxicities above Grade 1 from prior cancer therapies except hair loss
- Receiving other investigational agents
- Additional malignancy with brain metastases
- Recent serious cardiac events or conditions within 6 months including severe heart disease, heart attack, unstable angina, bypass surgery, heart failure, stroke, transient ischemic attack, or pulmonary embolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Keila Torres, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here