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Tyrosine Kinase Inhibitor
Avapritinib for Solid Tumors
Phase 2
Recruiting
Led By Jordi Rodon Ahnert
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males with female partners of reproductive potential must either abstain from sexual intercourse or they and their partners must use a highly effective method of contraception when engaging in sexual intercourse for the course of the study through 30 days after the last dose of study treatment
>= 18 years of age on the day of informed consent signing
Must not have
Known risk of intracranial bleeding, or a history of intracranial bleeding
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to study completion (estimated 4 years)
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
Adults with advanced or metastatic solid tumors harboring specific genetic mutations (CKIT or PDGFRA) may join this trial. They should have tried standard treatments without success, be able to follow the study protocol, and agree to use effective contraception. Those with certain heart conditions, unstable brain metastases, severe bleeding history, or on strong CYP3A4 inhibitors/inducers are excluded.
What is being tested?
The trial is testing avapritinib's effectiveness in stopping tumor growth by inhibiting enzymes needed for cell growth in patients with CKIT/PDGFRA mutation-positive malignant solid tumors that are locally advanced or have spread elsewhere.
What are the potential side effects?
Potential side effects of avapritinib include fatigue, nausea, swelling due to fluid retention, diarrhea, decreased appetite and potential risk of bleeding. Effects on heart rhythm and liver function may also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using or willing to use effective birth control during and for 30 days after the study.
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I am 18 years old or older.
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My cancer has a specific genetic change detected by a detailed test.
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My white blood cell count is healthy without needing medication in the last 2 weeks.
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My hemoglobin level is at least 9.0 g/dL without recent blood transfusions.
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I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a risk or history of bleeding in the brain.
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I do not have major stomach or bowel issues that affect how I absorb medicine.
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I cannot swallow or keep down pills.
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I have a non-healing wound, ulcer, or broken bone.
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I have a history of serious heart failure or heart rhythm problems.
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I have had a stroke or a mini-stroke in the past.
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I have been diagnosed with GIST (gastrointestinal stromal tumor).
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My cancer has a specific mutation resistant to certain medications.
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I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to study completion (estimated 4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to study completion (estimated 4 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate (ORR)
Secondary study objectives
Disease control rate (DCR)
Duration of response (DoR)
Incidence of adverse events
Side effects data
From 2021 Phase 1 trial • 250 Patients • NCT02508532100%
Decreased appetite
67%
Weight decreased
67%
Blood bilirubin increased
67%
Cough
67%
Dizziness
67%
Dysgeusia
33%
Memory impairment
33%
Face oedema
33%
Peripheral sensory neuropathy
33%
Anemia
33%
Hypoxia
33%
Constipation
33%
Mood altered
33%
Periorbital oedema
33%
Influenza like illness
33%
Insomnia
33%
Rash
33%
Dry skin
33%
Hypertension
33%
Neutropenia
33%
Lacrimation increased
33%
Dyspepsia
33%
Dry mouth
33%
Hypokalaemia
33%
Back pain
33%
Myalgia
33%
Hair colour changes
33%
Alopecia
33%
Dermatitis acneiform
33%
Contusion
33%
Leukopenia
33%
Hypophosphataemia
33%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD
Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (avapritinib)Experimental Treatment1 Intervention
Patients receive avapritinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avapritinib
2022
Completed Phase 1
~400
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,596 Total Patients Enrolled
58 Trials studying Sarcoma
18,857 Patients Enrolled for Sarcoma
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,988 Total Patients Enrolled
459 Trials studying Sarcoma
229,603 Patients Enrolled for Sarcoma
Jordi Rodon AhnertPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
35 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (avapritinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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