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Nirogacestat for Desmoid Tumors
Study Summary
This trial looks at the side effects and efficacy of nirogacestat in treating patients with desmoid tumors that have grown after at least one form of treatment. Nirogacestat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I haven't taken certain cancer drugs like sorafenib or tamoxifen in the last 28 days.I am currently breastfeeding.I am using effective birth control and will continue for 6 months after my last dose.I can do most activities or at least move around in a wheelchair.I haven't had chemotherapy in the last 2 weeks, or 4 weeks if it was nitrosourea.My body surface area is more than 0.3 square meters.I am a man who agrees to use contraception during and 90 days after treatment.I can swallow tablets without crushing or using a tube.I have not had an infection in the week before joining the study.I have a fracture that hasn't healed.I do not have an active hepatitis B, C, or HIV infection.I am currently pregnant.My heart's electrical activity is within a healthy range.I am a woman who can have children and have a negative pregnancy test.I agree not to use NSAIDs for my desmoid tumor treatment while in the study, except for occasional pain relief.My desmoid tumor was confirmed through a tissue examination.It has been over a week since my last biologic treatment.I haven't taken growth factor medications in the last week.I haven't taken any experimental drugs in the last 4 weeks and any side effects from past treatments have mostly gone away.My kidney function is good based on tests.I don't have a history of long QT syndrome.I haven't had serious heart issues or a stroke in the last 6 months.I am between 12 months and 18 years old.I have recovered from previous cancer treatments and am not planning any soon.My desmoid tumor can't be removed by surgery without high risk and has grown by 10% or more recently.I am not taking any strong medication that affects liver enzymes.My liver is working well, based on recent tests.I have had at least one treatment for my desmoid tumor.I haven't taken corticosteroids in the last 21 days, except for specific reasons.It's been weeks since my last local tumor treatment and any side effects are mild.I have not taken any gamma-secretase, Notch, or beta-catenin inhibitors.I have a stomach or intestine condition that affects how I absorb medicine.It's been over 21 days since my last antibody treatment and any side effects are mild.My platelet count is at least 100,000 and I haven't needed a transfusion.I had a stem cell transplant over 6 months ago with no current graft vs. host disease.I have had cancer before, but it wasn't skin cancer or desmoid tumors, and I've been in remission for less than 3 years.I have ulcerative colitis, inflammatory bowel disease, or a bowel obstruction.My hemoglobin level is at least 9.0 g/dL.
- Group 1: Treatment (nirogacestat)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is it possible to join the research team of this medical experiment?
"This trial is currently recruiting 35 children between 12 months and 18 years of age who are suffering from fibroma. Eligible patients must meet a range of criteria, including not having undergone cytotoxic chemotherapy within the 2 weeks prior to admission (4 weeks if nitrosourea was used), possessing body surface area greater than 0.3 m^2 at enrollment, presenting desmoid tumors that cannot be surgically removed without significant morbidity, being able to demonstrate measurable disease using RECIST v1.1 standards, and more. Furthermore, any therapies such as tyrosine kinase inhibitors or biologic agents should have been administered 28"
Is this research project accepting new participants?
"Affirmative. The information found on clinicaltrials.gov suggests that this medical trial is still searching for participants, having been initially posted in September of 2020 and last updated in October 2022. A total of 35 individuals need to be enrolled from 88 separate sites."
Are persons of advanced age eligible for inclusion in this experiment?
"This research study seeks participants who are younger than 18 and older than 12 months."
In which North American locations is this experimental research being conducted?
"88 medical centres across the United States are presently running this study, with Edmonton, East Lansing and Louisville being key locations. It is recommendable to select a clinic near you in order to reduce travel costs if you decide to join the trial."
Has Nirogacestat been given authorization from the FDA?
"Our team at Power gave Nirogacestat a score of 2, as the Phase 2 trial has thus far only demonstrated safety data and not efficacy."
Could you elaborate on the research that has been conducted concerning Nirogacestat?
"Nirogacestat was initially investigated in 2013 at the NIH Clinical Center located on Rockville Pike. To date, 231 trials have been finalized and 8 remain active, with a considerable amount being conducted out of Edmonton, Alberta."
How many participants have signed up for this experiment?
"Affirmative. According to information available on clinicaltrials.gov, this medical trial is actively recruiting at 88 sites as of October 21st 2022. The original posting for the study was made on September 21st 2020 and 35 patients are being sought out in total."
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