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FCN-159 for Neurofibromatosis
Study Summary
This trial is testing a new drug, FCN-159, to see if it can help treat patients with advanced solid tumors or neurofibromatosis type 1.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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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Who is running the clinical trial?
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- I have a neurofibroma that has grown along a nerve.I have not had radiotherapy, surgery, or immunotherapy in the last 4 weeks.I have swallowing difficulties or digestive problems that affect how my body absorbs food.I will avoid too much sun and use sunscreen if I'm in the sun.I am allergic to the study drug or similar medications.My NF1 causes or could cause serious health problems.I am between 16 and 70 years old and weigh at least 94 lbs (42.5 kg).My spinal nerve condition affects multiple levels and is connected or extends sideways.I have had issues with my eyes, like retinal vein occlusion or glaucoma.I have a unique bone condition affecting my skull or long bones.My high blood pressure is not under control.My NF1-related tumor needs treatment like chemo, radiation, or surgery.I have not used growth factors in the week before starting FCN-159.I have not been treated with selumetinib or any MEK 1/2 inhibitors.I have NF1 with plexiform neurofibromas needing treatment as advised by my doctor.I do not have serious heart problems or other major diseases.I have interstitial pneumonia.I do not have any ongoing infections.I haven't taken certain medications in the last 14 days.I've had chemotherapy for NF1 within the last 3 months and still experience significant side effects.I am mostly able to care for myself and carry out daily activities.I am between 2 and 15 years old and can swallow a tablet whole.I have been diagnosed with neurofibromatosis type 1 (NF1).I have a tumor that is at least 3 cm big and can be seen on an MRI.I have freckles under my arms or in the groin area.I have been diagnosed with neurofibromatosis type 1.You have at least 2 Lisch nodules (iris hamartomas).You need to meet at least one of the following criteria:I will avoid too much sun and use sunscreen if needed.I have two or more neurofibromas or at least one plexiform neurofibroma.
- Group 1: Single Arm
- 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
Are there numerous centers offering this research study in Canada?
"This clinical trial is running out of 4 sites across the country, including Detroit, Gainesville and Charleston. To reduce time spent traveling for patients enrolled in this study, it may be beneficial to choose a clinic closest to your home."
To what extent is the participant pool for this clinical trial expanding?
"Affirmative. Per the information housed on clinicaltrials.gov, this medical trial is in search of volunteer participants and was first launched on March 26th 2021. The study needs to find 160 patients from 4 different locations before it can be completed; its records were most recently updated on August 24th 2022."
Am I eligible to partake in the current investigation?
"This medical study is seeking 160 individuals between the ages of 2 and 70 diagnosed with Watson Syndrome. To qualify, applicants must meet one or more of the following criteria: have a body weight above 94 lbs/42.5 kg., possess axillary freckling or inguinal region freckles; be genetically confirmed to have an NF1 germline mutation (either from testing at the central laboratory for FCN-159-002 or documentation from a CLIA-approved centre); display six cafe-au-lait macules bigger than 0.5 cm pre-puberty, 1.5 cm post puberty; two neurof"
Is there an age requirement to participate in this medical study?
"As per the requirements of this trial, potential enrollees must be at least 2 years old and no older than 70."
Are there any opportunities currently available to volunteers for this research project?
"Clinicaltrials.gov affirms that this research is still actively looking for subjects to enrol, having been first posted on March 26th 2021 and most recently updated August 24th 2022."
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