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New treatment option for Mastocytosis, Systemic
Official title Avapritinib Rollover Study
ClinicalTrials.gov ID: NCT06748001
What this study is testing
What is Avapritinib?
Avapritinib is an investigational medicine, being studied as a potential treatment for mastocytosis, systemic.
Also referred to as BLU-285, AYVAKIT®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Participated in a Blueprint Medicines sponsored avapritinib clinical study. The Sponsor reserves the right to not roll over patients who have been on...
- 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.
You likely can't join if
- Participant is participating in another treatment study.
- Participant is unwilling or unable to comply with study procedures and study restrictions.
- Participant is breastfeeding. Other protocol-defined criteria apply.
See the full eligibility 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.
- Participant is participating in another treatment study.
- Participant is unwilling or unable to comply with study procedures and study restrictions.
- Participant is breastfeeding. Other protocol-defined criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Edegem, Belgium
- Toronto, Ontario, Canada
- Salerno, Italy
- Groningen, Netherlands
- Rotterdam, Netherlands
- Oslo, Norway
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edegem, Belgium; Toronto, Ontario, Canada; Salerno, Italy; Groningen, Netherlands; Rotterdam, Netherlands; Oslo, Norway and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.