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Avapritinib for Pediatric Solid Cancers
Study Summary
This trial is testing a new drug, avapritinib, for kids with cancer who have run out of treatment options. The trial will first test safety and how the body handles the drug (Part 1), then move on to testing how well the drug works against the cancer (Part 2).
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 2021 Phase 3 trial • 476 Patients • NCT03465722Trial Design
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- My platelet count is low and I haven't had a transfusion in the last 14 days.My brain disease treatment with steroids has been stable or reduced for a week.My diagnosis is DMG-H3K27a and standard treatments have not worked or are not available.My cancer has a PDGFRA or KIT mutation and has not responded to standard treatments.I am a male and either vasectomized, will use condoms, practice abstinence, or my partner cannot become pregnant.I can do most activities but need help with some.My liver enzymes are high, but not over five times the normal limit if my cancer affects my liver.My bilirubin levels are higher than normal, possibly due to Gilbert's syndrome.I have a serious heart condition that is not under control.I am willing and able to follow the study's schedule and procedures.I have been treated for a blood clot in the last 6 months.My hemoglobin level is below 8.0 g/dL and I haven't had a blood transfusion in the last week.I have received cancer treatment within specific time limits.My kidney function test shows creatinine levels higher than normal.I have been treated with avapritinib before.I am a woman able to have children and will not use effective birth control.I have not taken strong CYP3A inhibitors or inducers in the last 28 days.I have had another type of cancer before.I have a significant ongoing or past medical condition.I need blood thinners, but there might be exceptions.I am at risk for bleeding in my brain.I've had a stem cell transplant or CAR T cell therapy recently.I have not had major surgery within the last 14 days.I cannot swallow pills or the tiny tablets in sprinkle capsules.My seizure disorder is not well controlled despite medication.I am between 2 and 17 years old.I am using effective birth control or my partner is sterile.
- Group 1: avapritinib
- 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
How many people are currently involved in this experiment?
"37 patients that fit the inclusion criteria must enroll in this study. Multiple centres are available for patient participation, such as Dana Farber Cancer Institute located in Boston, Massachusetts and Columbia University Medical Center situated in New york, New York."
How many different research facilities are conducting this experiment?
"There are 26 participating centres in total, with 13 of them actively recruiting patients at the moment. These locations include the Dana Farber Cancer Institute in Boston, Columbia University Medical Center in New york, and Children's Hospital Colorado in Aurora."
Is this research the first to be conducted on this topic?
"Avapritinib clinical trials are ongoing in 37 cities and 18 countries. The first study began in 2018, involving 103 individuals and sponsored by Blueprint Medicines Corporation. To date, 3 avapritinib trials have completed Phase 2 drug approval stages."
Are there any other drugs that have been trialed alongside avapritinib in the past?
"avapritinib was first researched in 2018 at Universitätsmedizin Mannheim III. Medizinische Klinik. So far, there have been three completed clinical trials with seven more currently underway across the United States of America, many centred in Boston, Massachusetts."
Does this experimental treatment program accept patients who are over 20 years old?
"Children aged 2 to 17 can enroll in this particular trial, according to the inclusion criteria. Out of 3201 total trials, 321 are for patients under 18 and 2280 are for senior citizens."
What are the prerequisites for joining this clinical trial?
"The prerequisites for this particular clinical trial are that the patient has relapsed solid neoplasm and is between 2 to 17 years old. There is a total of 37 slots available for participants."
Can new patients join this clinical trial?
"From what is published on clinicaltrials.gov, it appears that the trial is searching for participants. The listing shows that the 37 patients are needed at 13 different sites and the original posting was on February 24th, 2022 with the most recent update being November 11th, 2022."
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