Avapritinib Rollover Study
ConditionMastocytosis, Systemic
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBlueprint Medicines Corporation
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Participant is participating in another interventional study.
Participant is unwilling or unable to comply with study procedures and study restrictions.
Participant is breastfeeding.
Trial design
Design model
Single group
Treatments tested in this trial
Avapritinib
DrugAvapritinib will be administered in accordance with the parent study protocol.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: AvapritinibExperimental treatment 1 intervention
Trial outcomes
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov