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Miransertib for Proteus Syndrome
Study Summary
This trial is testing if a new drug, miransertib, is safe and effective in treating Proteus syndrome, a rare overgrowth disorder. People ages 3 and older with Proteus syndrome who participate will take a miransertib pill once a day for 4 years and have 20-30 visits to the NIH for checkups.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am between 3 and 16 years old with a measurable foot tumor and a body surface area of at least 0.33 m^2.I do not have any severe illnesses unrelated to Proteus syndrome.I have diabetes that is not well-controlled with medication other than metformin.I haven't had serious heart problems in the last 6 months.I am over 3 years old, have used or am using miransertib, and my body surface area is at least 0.33 m^2.I haven't had major surgery, radiotherapy, or immunotherapy in the last 4 weeks.I am not taking any medications that are not allowed in the study.I use tobacco, CBD/THC, or vape regularly.I am over 3 years old, don't fit in Cohorts 1 or 3, and my body surface area is at least 0.33 m^2.I have Proteus syndrome with a confirmed AKT1 mutation.My cancer has grown or spread in the last year.I currently have an infection.I have had severe side effects from AKT inhibitor treatments.I haven't taken any experimental drugs for Proteus syndrome in the last 2 weeks, except miransertib.I have HIV with malabsorption syndrome.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Group 1: MK-7075 (miransertib)
- 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
Are there any current vacancies for this particular clinical trial?
"That is correct. Information available on clinicaltrials.gov reveals that this study, which was first advertised on May 20th, 2022, is still recruiting patients. The research team hopes to enroll 45 individuals from a single location."
What other scientific research has looked into the effects of Miransertib (ARQ092)?
"At the moment, there are 2 ongoing clinical trials testing Miransertib (ARQ092). Of these tests, 0 are in Phase 3. Several of the trials for Miransertib (ARQ092) occur near Bethesda, Maryland; however, there are a total of 12 different locations running trials for Miransertib (ARQ092)."
How many guinea pigs are needed for this test?
"That is correct, the online information regarding this clinical trial reveals that it is currently looking for 45 individuals to participate at a single site. The trial was established on May 20th, 2020 and was most recently updated on October 29th, 2020."
When will Miransertib be available for general medical use?
"For now, Miransertib (ARQ092) has only been proven safe in clinical trials. As such, it received a score of 2."
Is this the initial research done on this topic?
"Research for Miransertib (ARQ092) began in 2021 with a initial study sponsored by Merck Sharp & Dohme Corp. The first trial, which had 60 participants, occurred that same year and resulted in the drug being approved for Phase 2 clinical trials. Now, there are 2 ongoing studies involving Miransertib (ARQ092) across 12 cities and 5 countries."
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