Cryoablation + Nirogacestat for Desmoid Tumors
Trial Summary
What is the purpose of this trial?
The primary purpose of this protocol is Systemic therapy with oral study agent, nirogacestat, followed by a single cryoablation procedure.
Do I need to stop my current medications to join the trial?
Yes, if you are currently taking any treatment for desmoid tumors, you must stop at least 28 days before starting the study treatment. If you are on chronic NSAIDs for other conditions, you need to be on a stable dose for at least 28 days before starting the study treatment.
What data supports the effectiveness of the treatment Cryoablation + Nirogacestat for Desmoid Tumors?
Is cryoablation safe for treating desmoid tumors?
What makes the treatment with Nirogacestat for Desmoid Tumors unique?
Nirogacestat is a unique treatment for Desmoid Tumors because it is a gamma-secretase inhibitor, which targets a specific pathway involved in tumor growth, unlike traditional treatments that may not specifically target this pathway. Additionally, combining it with cryoablation (a procedure that freezes and destroys abnormal tissue) offers a novel approach that may enhance treatment effectiveness.7891011
Research Team
Nam Bui, M.D.
Principal Investigator
Stanford University
Eligibility Criteria
Adults with a confirmed diagnosis of desmoid tumor that is either growing or causing symptoms, and who can swallow tablets. The tumor must be partially treatable by cryoablation without harming nearby critical structures. Participants need proper organ function, no severe cardiac issues or recent heart attacks, and cannot be on certain medications. Women must not be pregnant or breastfeeding and use contraception; men agree to use condoms.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Systemic therapy with oral study agent, nirogacestat, for 3 cycles (1 cycle = 28 days) followed by a single cryoablation procedure, then continued nirogacestat for Cycles 4 through 26
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cryoablation
- Nirogacestat
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
SpringWorks Therapeutics, Inc.
Industry Sponsor