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NCT Number: NCT06748001

Avapritinib Rollover 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.

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Key information

Conditions

Mastocytosis, Systemic Immune System Diseases Mast Cell Activation Disorders Mastocytosis Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitair Ziekenhuis Antwerpen (UZA), Edegem, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avapritinib

Drug

Avapritinib will be administered in accordance with the parent study protocol.

Other names: BLU-285, AYVAKIT®

Primary outcomes

  1. Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs leading to Discontinuation

    Time frame: Up to approximately 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

Blueprint Medicines

CONTACT

[email protected]

617-714-6707

Sponsors and collaborators

Lead sponsor

Blueprint Medicines Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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