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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Universitair Ziekenhuis Antwerpen (UZA)
RECRUITING
Edegem
Canada
The Hospital for Sick Children
RECRUITING
Toronto
Italy
A.O.U. San Giovanni di Dio e Ruggi d'Aragona di Salerno
RECRUITING
Salerno
Netherlands
Erasmus Medisch Centrum
RECRUITING
Rotterdam
Norway
Oslo University Hospital
RECRUITING
Oslo
United Kingdom
Guys and St Thomas NHS Foundation Trust - St Thomas Hospital
RECRUITING
London
Contact Information
Primary
Blueprint Medicines
MedInfo@blueprintmedicines.com
617-714-6707
Time Frame
Start Date: 2024-11-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Avapritinib
Participants who have participated in a Blueprint Medicines sponsored study (the parent study) and continue to benefit from avapritinib.
Sponsors
Leads: Blueprint Medicines Corporation

This content was sourced from clinicaltrials.gov