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Gamma Secretase Inhibitor
Cryoablation + Nirogacestat for Desmoid Tumors
Phase 2
Recruiting
Led By Nam Bui, M.D.
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial tests a new drug and procedure to treat tumors.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial tests the effectiveness of nirogacestat taken orally followed by a single cryoablation procedure for treating desmoid tumors. Nirogacestat is given first to potentially shrink the tumor before freezing it with cryoablation to destroy remaining cancer cells.See study design
What are the potential side effects?
Potential side effects may include reactions related to cold temperatures from cryoablation affecting nearby tissues and typical drug-related effects such as digestive disturbances, liver enzyme changes, blood disorders, fatigue, and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Benefit per RECIST v1.1
Secondary outcome measures
Clinical Benefit per mRECIST
Duration of Response (DoR)
Objective Response
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Nirogacestat 150 mgExperimental Treatment2 Interventions
Patients will receive 3-cycle lead-in with systemic therapy with nirogacestat 150 mg po BID, given continuously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoablation
2016
Completed Phase 2
~1040
Find a Location
Who is running the clinical trial?
SpringWorks Therapeutics, Inc.Industry Sponsor
12 Previous Clinical Trials
943 Total Patients Enrolled
3 Trials studying Desmoid Tumors
142 Patients Enrolled for Desmoid Tumors
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,327 Total Patients Enrolled
Nam Bui, M.D.Principal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow pills.My desmoid tumor can be mostly treated with freezing.I haven't taken strong or moderate CYP3A4 inhibitors or inducers in the last 14 days.I have had a serious cancer within the last 2 years.I haven't had major heart or stroke issues in the last 6 months.I have been treated with GS inhibitors or anti-Notch antibody therapy.I do not have an ongoing or chronic infection.I do not have a condition that affects how my body absorbs medication.I have a history of liver disease or liver abnormalities.My heart's electrical activity is normal after adjusting for electrolytes.I have a genetic heart condition known as long QT syndrome.I finished my treatment for DT 28 days ago and have no major side effects.I am 18 years old or older.My lab tests show my organs and bone marrow are working well.I am using birth control consistently.I am currently taking medication for desmoid tumors, including TKIs or NSAIDs.I can take care of myself and am up and about more than half of my waking hours.My tumor is large or oddly shaped and close to important body parts, making it hard to treat in one go.I have been on a stable dose of NSAIDs for conditions other than DT for at least 28 days.My desmoid tumor is growing or causing symptoms.I am not taking any medications that affect my heart's rhythm.I have risk factors for a specific heart rhythm problem.
Research Study Groups:
This trial has the following groups:- Group 1: Nirogacestat 150 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Nirogacestat 150 mg been sanctioned by the Food and Drug Administration?
"As this is a Phase 2 study with some evidence of safety but no data to back up efficacy, Nirogacestat 150 mg received a score of 2."
Answered by AI
Are individuals eligible to enroll in this clinical investigation at present?
"Data displayed on clinicaltrials.gov indicates that this investigation is no longer enrolling patients, after being first uploaded on August 1st 2023 and last edited July 7th 2023. However, there are 15 alternative trials that have opened their doors to participants at the present time."
Answered by AI
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