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AZD6244 for Neurofibromatosis
Study Summary
This trial is testing a drug to see if it can prevent, slow down the growth, or shrink tumors in children and young adults with plexiform neurofibromas.
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.Side effects data
From 2020 Phase 2 trial • 334 Patients • NCT01248247Trial Design
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Who is running the clinical trial?
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- I cannot swallow pills.I am currently receiving cancer treatment such as radiation, chemotherapy, or immunotherapy.I am mostly active and can care for myself.My kidney function is normal or only mildly impaired.I do not have severe illness, active infections, bleeding disorders, kidney transplant, hepatitis C, or HIV.I have been diagnosed with or tested positive for NF1.My blood pressure is within the normal range for my age, height, and gender.My liver tests are within the required range.My heart pumps well and my heart rhythm is normal.I have ongoing nausea, vomiting, or serious gut issues.I have previously been treated with a MEK1/2 inhibitor.I have been diagnosed with a specific type of cancer.I am not taking any medications that could affect the study drugs.I am between 3 and 18 years old and can swallow capsules.I am between 2 and 18 years old, can swallow capsules, and my body surface area is at least 0.55 m2.I have NF1 with tumors that can't be removed and may cause serious health problems.My blood pressure is not well controlled.I have an eye condition.I have not had major surgery in the last 4 weeks.I have ongoing side effects from anti-NF1 treatment.I need surgery within the first three treatment cycles.I have a known heart condition.
- Group 1: Arm 2
- Group 2: Arm 1
- 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
Could individuals aged 60 and above participate in the experiment?
"According to the official requirements for participation, this study only accepts patients aged between 2 and 18 years old."
Is this experiment currently open to participants?
"Unfortunately, this medical trial is no longer recruiting participants. The clinical trial was initiated on September 21st 2011 and last updated November 19th 2022. If you are looking for similar studies, there are currently 58 trials researching watson syndrome and 34 investigating AZD6244 that have open enrollment periods."
At which venues is this trial being administered?
"This clinical study is available at seven distinct medical sites, including Children's National Medical Center in Washington D.C., Cincinnati Children's Hospital Medical Centre in Ohio and the prestigious NIH Clinical Center located in Bethesda Maryland."
Have any other investigations taken place involving AZD6244?
"In 2007, AZD6244 was initially studied at Research Site. 60 completed trials have taken place since then and 34 live studies are currently active - many of these located in the District of Columbia's capital, Washington DC."
Which population is most suited to participate in this clinical study?
"This medical trial is seeking to enroll ninety-nine individuals between the ages of two and eighteen who suffer from Watson Syndrome. To qualify, candidates must possess at least six cafe au lait macules (with dimensions being 0.5cm in prepubertal participants or 1.5 cm for post pubertal patients), freckling within their armpits or groin, optic glioma, Lisch nodules, a distinctive bone abnormality in either their sphenoid or long bones as well as body surface area greater than 0.55 m2 if they are able to swallow whole capsules. This age range was specifically chosen"
How does this research endeavor seek to benefit patients?
"This three-cycle clinical trial seeks to assess the efficacy of selumetinib in treating NF1 and inoperable PN among children and young adults. Additional aims include measuring long term safety, evaluating growth rate of PN, and determining objective response rates."
Is there a cap on the number of participants in this medical trial?
"This research is no longer recruiting participants. It first appeared on September 21st 2011 and was last updated November 19th 2022. However, 58 clinical studies are accepting Watson Syndrome patients while 34 centres are enrolling candidates for AZD6244 trials."
Is this research effort a pioneering endeavor?
"AZD6244 has been in clinical trials since 2007, when AstraZeneca initiated the first study with 58 participants. Thanks to positive results from that trial, AZD6244 was granted Phase 1 drug approval and is now being tested in 34 active studies across 33 different countries and 156 cities."
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