Avapritinib Rollover Study

Phase 4RecruitingNCT06748001

Blueprint Medicines Corporation60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mastocytosis, Systemic

Interventions

AvapritinibDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (7)

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Belgium

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

A.O.U. San Giovanni di Dio e Ruggi d'Aragona di Salerno

Salerno, Italy

Outcomes

Primary Outcomes

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

Time frame: Up to approximately 4 years

Central Contacts

Blueprint Medicines

CONTACT

617-714-6707 MedInfo@blueprintmedicines.com

Data from ClinicalTrials.gov

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