Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07543822 · ClinicalTrials.gov registry record · Phase 2
24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs
A Phase 2 study, sponsored by Children's Hospital of Philadelphia.
- Active
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT07543822 is a Phase 2 study that is active but no longer recruiting, run by Children's Hospital of Philadelphia. The registered enrollment target is 61 participants.
The verdict
NCT07543822, a Phase 2 study, is active but no longer recruiting, sponsored by Children's Hospital of Philadelphia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
The study will enroll participants 2 months of age up to 30 years of age. The purpose of this study is to assess the effectiveness and safety of Alpelisib (the "Study Drug") in patients with PIK3CA/TIE-2/TEK pathway driven vascular anomalies (VA). Alpelisib has been approved by the U.S. Food and Drug Administration (FDA) for treating adults and children with certain types of breast cancer. Its use in this study is considered experimental because FDA has not approved the study drug for treating people with VAs. Study participation will last for up to 3 years and will involve regular study visits to Children's Hospital of Philadelphia (CHOP)'s Philadelphia Campus. Participants will need to take the study drug Alpelisib for at least 2 years, or up to 3 years in total if there is a positive response. Participating in this research means you will attend up to 16 clinic visits for the purposes of the study. Most visits will take approximately 30 minutes, but some visits will take approximately 2 hours, because you will be asked to complete questionnaires about your experience. Participating in this research also means taking the study drug, having pictures taken, and completing study drug diaries. There is also an optional portion to this study that involves collecting blood for biomarker testing.
Interventions
- DRUG alpelisib (BYL719)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2025-08-27 |
| Est. Completion | 2030-08-27 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07543822
The ClinicalTrials.gov registry entry for NCT07543822 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which alpelisib (BYL719) is the first listed.
NCT07543822 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07543822 about?
NCT07543822 is a clinical study titled "24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs". The study will enroll participants 2 months of age up to 30 years of age. The purpose of this study is to assess the effectiveness and safety of Alpelisib (the "Study Drug") in patients with PIK3CA/TIE-2/TEK pathway driven vascular anomalies (VA). Alpelisib has been approved by the U.S. Food and Dru...
What is the current status of trial NCT07543822?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2025-08-27. Estimated completion is 2030-08-27.
What interventions are being tested in trial NCT07543822?
The interventions under investigation include: alpelisib (BYL719) (DRUG).
Who is sponsoring clinical trial NCT07543822?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.