Long-term safety evaluation of avapritinib for mastocytosis patients
An Open-label, Multicenter, Rollover Study in Patients Who Participated in an Avapritinib Clinical Study
This study is testing the long-term safety of avapritinib for patients with mastocytosis who have already benefited from the treatment in a previous study.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Blueprint Medicines Corporation Industry-sponsored |
| Drugs / interventions | avapritinib |
| Locations | 7 sites (Edegem and 6 other locations) |
| Trial ID | NCT06748001 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the long-term safety of avapritinib in patients who have previously participated in a clinical study sponsored by Blueprint Medicines and have shown continued clinical benefit from the treatment. Participants will be monitored for safety outcomes as they continue receiving avapritinib. The study is designed for individuals who have completed the parent study and meet specific eligibility criteria. The focus is on patients with indolent and advanced systemic mastocytosis.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have completed a prior avapritinib clinical study and continue to benefit from the treatment.
Not a fit: Patients who are currently participating in another interventional study or are unwilling to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety of avapritinib, potentially leading to improved treatment options for patients with systemic mastocytosis.
How similar studies have performed: Other studies involving avapritinib have shown promising results, indicating a potential for continued success in this rollover study.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Edegem and 6 other locations
- Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Belgium (Recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
- A.O.U. San Giovanni di Dio e Ruggi d'Aragona di Salerno — Salerno, Italy (Recruiting)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (Recruiting)
- Erasmus Medisch Centrum — Rotterdam, Netherlands (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Guys and St Thomas NHS Foundation Trust - St Thomas Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Blueprint Medicines
- Email: MedInfo@blueprintmedicines.com
- Phone: 617-714-6707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.