Avapritinib Rollover Study

February 5, 2026 updated by: Blueprint Medicines Corporation

An Open-label, Multicenter, Rollover Study in Patients Who Participated in an Avapritinib Clinical Study

The primary objective of the rollover study is to evaluate the long-term safety of avapritinib in participants who have completed a Blueprint Medicines sponsored study (parent study) and continued to benefit from avapritinib.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen (UZA)
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children
  • Italy
      • Salerno, Italy, 84131
        • Recruiting
        • A.O.U. San Giovanni di Dio e Ruggi d'Aragona di Salerno
  • Netherlands
      • Groningen, Netherlands, 9700
        • Recruiting
        • Universitair Medisch Centrum Groningen
      • Rotterdam, Netherlands, 3015
        • Recruiting
        • Erasmus Medisch Centrum
  • Norway
      • Oslo, Norway, 0424
        • Recruiting
        • Oslo University Hospital
  • United Kingdom
      • London, United Kingdom, SE19RT
        • Recruiting
        • Guys and St Thomas NHS Foundation Trust - St Thomas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participated in a Blueprint Medicines sponsored avapritinib clinical study. The Sponsor reserves the right to not roll over patients who have been on drug hold for an extended time period.
  • Completed End of Trial / End of Study (EOT/EOS) visit in the parent study and demonstrated compliance with the parent study requirements.
  • Continue to clinically benefit from treatment with avapritinib.
  • Able to give written informed consent.
  • Agree to continue to use highly effective contraception as defined in this protocol.
  • Female patients of childbearing potential must have negative highly sensitive serum pregnancy test within 20 days before the first dose of avapritinib. Women of nonchildbearing potential do not require this test.

Exclusion Criteria:

  • Participant is participating in another interventional study.
  • Participant is unwilling or unable to comply with study procedures and study restrictions.
  • Participant is breastfeeding.

Other protocol-defined criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Avapritinib
Participants who have participated in a Blueprint Medicines sponsored study (the parent study) and continue to benefit from avapritinib.
Drug: Avapritinib
Avapritinib will be administered in accordance with the parent study protocol.
Other Names:
  • BLU-285
  • AYVAKIT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs leading to Discontinuation
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blueprint Medicines Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 24, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLU-285-2404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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