Avapritinib Rollover Study

Blueprint Medicines

Status and phase: Enrolling; Phase 4

Conditions: Mastocytosis, Systemic

Treatments: Drug: Avapritinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06748001

BLU-285-2404

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Avapritinib

Experimental group

Description:

Participants who have participated in a Blueprint Medicines sponsored study (the parent study) and continue to benefit from avapritinib.

Treatment:

Drug: Avapritinib