Clinical trial · Interventional
Avapritinib Rollover Study
An Open-label, Multicenter, Rollover Study in Patients Who Participated in an Avapritinib Clinical Study
NCT06748001CI-TRIAL-00102816recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mastocytosis, Systemic | Systemic Mastocytosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avapritinib | Drug | Avapritinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avapritinib
- description
- Participants who have participated in a Blueprint Medicines sponsored study (the parent study) and continue to benefit from avapritinib.
- interventionNames
- Drug: Avapritinib
Primary outcomes (1)
- measure
- Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs leading to Discontinuation
- timeFrame
- Up to approximately 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.