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Kinase Inhibitor

Avapritinib Interaction with Midazolam for Cancer

Phase 1

Recruiting

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 approximately 2 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 approximately 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

area under the plasma concentration-time curve (AUC) of midazolam

maximum plasma concentration (Cmax) of midazolam

time of maximum plasma concentration (tmax) of midazolam

Secondary outcome measures

Cmax at steady state (Cmax, ss) of avapritinib

Cmax at steady state (Cmax, ss) of metabolite

Number of adverse events (AEs), serious AEs (SAEs)

+2 more

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

2015

Completed Phase 1

~340

midazolam

2019

Completed Phase 4

~3010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Blueprint Medicines CorporationLead Sponsor

29 Previous Clinical Trials

6,199 Total Patients Enrolled

Media Library

Avapritinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04908176 — Phase 1

Brain Tumor Research Study Groups: Participants with metastatic, unresectable GIST, non-CNS solid tumors, or CNS tumors

Brain Tumor Clinical Trial 2023: Avapritinib Highlights & Side Effects. Trial Name: NCT04908176 — Phase 1

Avapritinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04908176 — Phase 1

Frequently Asked Questions

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

Is the research study currently recruiting participants?

"According to clinicaltrials.gov, this medical experiment is presently in need of participants. This study was first made public on August 24th 2022 and its details were most recently modified on September 25th 2022."

Answered by AI

What malignancies are addressed with treatment using Participants with metastatic, unresectable GIST, non-CNS solid tumors, or CNS tumors?

"Patients with metastatic, unresectable GIST, non-CNS solid tumors, and CNS tumors can be prescribed this medication to treat preoperative sedation. It is also often administered for anaesthesia therapy, seizure management in epileptics, and amnesia relief."

Answered by AI

Are previous research efforts known to have investigated individuals with metastatic, inoperable GISTs, non-brain solid tumors or brain tumors?

"Currently, 71 clinical trials for treating metastatic, unresectable GIST, non-CNS solid tumors and CNS tumors are actively running. Of these studies, 10 have advanced to the final stage of testing (Phase 3). Although a large number of those studies originate in Toronto Ontario 829 other sites around the world provide treatment options too."

Answered by AI

Is the FDA sign-off given to those with metastatic, unresectable GIST, non-CNS solid tumors or CNS tumors?

"According to our team at Power, the safety of participants with metastatic, unresectable GIST, non-CNS solid tumors or CNS tumors is rated 1 due to this being a Phase 1 trial and therefore limited supporting evidence for both its efficacy and security."

Answered by AI

How many individuals are enrolled in this clinical experiment?

"Affirmative. The clinical trial details available on clinicaltrials.gov suggest that this medical investigation is currently enrolling volunteers. This study, which was initially posted on August 24th 2022 and recently updated on September 25th 2022, requires 20 participants to be recruited from a single site of care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Drug-drug Interaction Study of Avapritinib and Midazolam

2022. "A Drug-drug Interaction Study of Avapritinib and Midazolam". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04908176.