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Kinase Inhibitor
Avapritinib Interaction with Midazolam for Cancer
Phase 1
Waitlist Available
Research Sponsored by Blueprint Medicines Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will look at the effect of a drug called avapritinib on midazolam in people with certain types of cancer.
Who is the study for?
Adults with advanced solid tumors that can't be surgically removed, specifically those with KIT mutations and have tried standard treatments without success. This includes certain brain tumors and gastrointestinal stromal tumors (GIST). Participants must be able to take oral medication, have a performance status indicating they are relatively active, and agree to use contraception.
What is being tested?
The trial is testing how avapritinib affects the body's handling of midazolam in patients with specific types of cancer. Avapritinib is given multiple times to see its impact on the pharmacokinetics (how the drug moves through the body) of midazolam.
What are the potential side effects?
Possible side effects include issues related to liver function tests like increased enzymes, potential bleeding risks especially for those with brain tumors or previous bleeding events, heart rhythm changes (QT prolongation), and other symptoms based on individual health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: Participants with metastatic, unresectable GIST, non-CNS solid tumors, or CNS tumorsExperimental Treatment2 Interventions
Participants will receive 5 mg of midazolam orally on Day 1 and Day 17. Participants will receive avapritinib 300 mg daily, orally on starting on Day 3. Participants with CNS tumors will receive avapritinib 300 mg daily orally, until Day 56.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avapritinib
2022
Completed Phase 1
~400
midazolam
2019
Completed Phase 4
~3010
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Who is running the clinical trial?
Blueprint Medicines CorporationLead Sponsor
29 Previous Clinical Trials
6,198 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to avapritinib or midazolam.You have a type of cancer called KIT mutant GIST that has spread to other parts of your body and cannot be removed by surgery. You have already tried at least 4 different treatments or your doctor has determined that the standard treatment is not suitable for you after trying at least 2 different treatments.You have already been treated with avapritinib before.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with metastatic, unresectable GIST, non-CNS solid tumors, or CNS tumors
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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