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Avapritinib for Solid Tumors
Study Summary
This trial will study the effect of avapritinib on treating solid tumors that have spread and have a genetic mutation in CKIT or PDGFRA. Avapritinib may stop cell growth by blocking enzymes needed for cell growth.
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 1 trial • 250 Patients • NCT02508532Trial Design
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Who is running the clinical trial?
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- I haven't had any blood clot events in the past 6 months.I haven't had cancer treatment or major surgery in the last 2 weeks and have recovered from side effects.I cannot swallow or keep down pills.I am a woman who cannot become pregnant due to age, surgery, or confirmed by a test.I do not have major stomach or bowel issues that affect how I absorb medicine.I have a non-healing wound, ulcer, or broken bone.I have stable brain metastases or have recovered from brain radiation with no worsening shown on MRI.I am using or will use effective birth control during and up to 6 weeks after the study.I have a risk or history of bleeding in the brain.I have a history of serious heart failure or heart rhythm problems.I have had a stroke or a mini-stroke in the past.I have not had severe bleeding in the last 4 weeks.Your heart's QT interval, when adjusted using a specific formula, is longer than 470 milliseconds.My cancer has spread, and standard treatments haven't worked or aren't suitable for me.My kidney function is within the required range for the study.My cancer can be measured by specific medical criteria.I have been diagnosed with GIST (gastrointestinal stromal tumor).I am using or willing to use effective birth control during and for 30 days after the study.I am 18 years old or older.I have tissue samples available for specific genetic testing.My cancer has a specific genetic change detected by a detailed test.My white blood cell count is healthy without needing medication in the last 2 weeks.My hemoglobin level is at least 9.0 g/dL without recent blood transfusions.I am willing to have a biopsy for the study.I am not currently using strong medications that affect liver enzymes.My platelet count is high enough without needing a transfusion in the last 2 weeks.My cancer has a specific mutation resistant to certain medications.Your heart's pumping function is normal, as shown by a recent heart test.I have another cancer, but it's not getting worse or needing treatment, except for certain skin cancers or cervical cancer that's been treated.My seizures are not under control, or my medication dose has increased recently.My mental health condition has been stable on medication for at least a year.I am not pregnant or breastfeeding.You are expected to live for at least 3 more months.Your total bilirubin level should be within a certain range, unless you have liver metastases.Your liver enzymes (AST and ALT) should not be more than 2.5 times the upper limit of normal. If you have cancer spread to the liver, the liver enzymes should not be more than 5 times the upper limit of normal.I can take care of myself and am up and about more than half of my waking hours.Your white blood cell count is between 2,500 and 15,000 per microliter within the last 28 days.
- Group 1: Treatment (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
Has Avapritinib been sanctioned by the US Food and Drug Administration?
"Though there is clinical data confirming Avapritinib's safety, the lack of efficacy research assigns it a score of 2."
Is this research a novel endeavor?
"Research on avapritinib has been conducted since 2018, when the first sponsored trial of 103 participants was concluded by Blueprint Medicines Corporation. Thanks to its success in Phase 2 trials, this drug is now available for study worldwide with 7 active clinical trials being held across 37 cities and 18 countries."
Are there still opportunities to participate in this experiment?
"This trial is currently recruiting patients, with the original posting taking place on January 20th 2021 and the most recent edit occurring June 9th 2022. This can be confirmed on clinicaltrials.gov."
What other experiments have been conducted to assess the efficacy of Avapritinib?
"Currently, Avapritinib is the focus of 7 active clinical trials with none in Phase 3. Across 106 different trial sites worldwide - a majority of them located in Toronto, Ontario- researchers are studying this drug's efficacy and safety profile."
What is the total number of participants currently participating in this research?
"Affirmative. Clinicaltrials.gov's records demonstrate that this trial, which was initiated on January 20th 2021, is actively in search of volunteers. Approximately 50 individuals need to be recruited from 1 centre."
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