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Avapritinib Rollover Study
RECRUITINGPhase 4Sponsored by Blueprint Medicines Corporation
Actively Recruiting
PhasePhase 4
SponsorBlueprint Medicines Corporation
Started2024-11-28
Est. completion2027-12-31
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06748001
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
Healthy volunteers accepted
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.
Conditions2
CancerMastocytosis, Systemic
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 4
SponsorBlueprint Medicines Corporation
Started2024-11-28
Est. completion2027-12-31
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06748001