Avapritinib Rollover Study

NCT06748001 · tracked via the Priya Life Science UK tracker

Sponsor

Blueprint Medicines Corporation

Phase

Phase 4

Started

2024-11-28

Last updated

2026-02-09

Condition(s) studied

Mastocytosis, Systemic

Investigational drug(s) / intervention(s)

Avapritinib

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

Study summary

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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs leading to Discontinuation — Up to approximately 4 years

Trial sites (7)

Facility	City	Region	Status
Universitair Ziekenhuis Antwerpen (UZA)	Edegem	Belgium	Recruiting
The Hospital for Sick Children	Toronto	Ontario	Recruiting
A.O.U. San Giovanni di Dio e Ruggi d'Aragona di Salerno	Salerno	Italy	Recruiting
Universitair Medisch Centrum Groningen	Groningen	Netherlands	Recruiting
Erasmus Medisch Centrum	Rotterdam	Netherlands	Recruiting
Oslo University Hospital	Oslo	Norway	Recruiting
Guys and St Thomas NHS Foundation Trust - St Thomas Hospital	London	United Kingdom	Recruiting

More Blueprint Medicines Corporation trials in the UK

(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis Active, not recruiting

(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis Recruiting

Other trials for the same condition

(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06748001 on ClinicalTrials.gov ↗ ← All trials in the UK