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Clinical Trials in Italy / NCT06748001
Recruiting Phase 4

Avapritinib Rollover Study

NCT06748001 · tracked via the Priya Life Science Italy 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
No
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)

FacilityCityRegionStatus
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 Italy

(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis Recruiting
(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
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU) Active, not 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 Italy