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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
Females must be postmenopausal (defined as >= 45 years of age with at least 12 months of spontaneous amenorrhea) or premenopausal with documented surgical sterilization (tubal ligation, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or evidence of non-childbearing status for women of childbearing potential (negative serum beta-human chorionic gonadotropin pregnancy test) within 3 days of study treatment initiation
Females of childbearing potential must either abstain from heterosexual intercourse or use a highly effective method of contraception for the course of the study through 6 weeks after the last dose of avapritinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to study completion (estimated 4 years)
Awards & highlights

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.

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.Check my eligibility
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.See study design
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 below
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I am a woman who cannot become pregnant due to age, surgery, or confirmed by a test.
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I am using or will use effective birth control during and up to 6 weeks after the study.
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My cancer has spread, and standard treatments haven't worked or aren't suitable for me.
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My kidney function is within the required range for the study.
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My cancer can be measured by specific medical criteria.
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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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I have tissue samples available for specific genetic testing.
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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 am willing to have a biopsy for the study.
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My platelet count is high enough without needing a transfusion in the last 2 weeks.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to study completion (estimated 4 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to study completion (estimated 4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DoR)
Incidence of adverse events

Side effects data

From 2021 Phase 1 trial • 250 Patients • NCT02508532
100%
Decreased appetite
67%
Cough
67%
Weight decreased
67%
Dizziness
67%
Blood bilirubin increased
67%
Dysgeusia
33%
Memory impairment
33%
Hypoxia
33%
Peripheral sensory neuropathy
33%
Constipation
33%
Mood altered
33%
Periorbital oedema
33%
Influenza like illness
33%
Insomnia
33%
Anemia
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%
Face oedema
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

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
2015
Completed Phase 1
~340

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,315 Total Patients Enrolled
102 Trials studying Melanoma
25,294 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,297 Total Patients Enrolled
557 Trials studying Melanoma
193,183 Patients Enrolled for Melanoma
Jordi Rodon AhnertPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Avapritinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04771520 — Phase 2
Melanoma Research Study Groups: Treatment (avapritinib)
Melanoma Clinical Trial 2023: Avapritinib Highlights & Side Effects. Trial Name: NCT04771520 — Phase 2
Avapritinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04771520 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~10 spots leftby Feb 2025