Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum
Public ClinicalTrials.gov record NCT04589650. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
EPIK-P2: A Phase II Double-blind Study With an Upfront, 16-week Randomized, Placebo-controlled Period, to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
Study identification
- NCT ID
- NCT04589650
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 206 participants
Conditions and interventions
Conditions
Interventions
- Alpelisib Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 0 Days to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 18, 2021
- Primary completion
- Mar 19, 2024
- Completion
- Jan 8, 2031
- Last update posted
- Apr 29, 2026
2021 – 2031
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF Birthmarks and Vascular Center | San Francisco | California | 94158 | — |
| Childrens Hospital Colorado | Aurora | Colorado | 80045 | — |
| Washington Univ School Of Medicine | St Louis | Missouri | 63110 | — |
| Fink Childrens Ambulatory Care Ctr | New York | New York | 10016 | — |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Cinn Children Hosp Medical Center | Cincinnati | Ohio | 45206 | — |
| Cincinnati Children s Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| CHOP Abramson Pediatric Resch Ctr | Philadelphia | Pennsylvania | 19104 | — |
| Unv of TX Southwestern Medical Center | Dallas | Texas | 75235 | — |
| Baylor College Of Medicine | Houston | Texas | 77030 | — |
| Childrens Hospital and Regional Medical Center | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04589650, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2026 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04589650 live on ClinicalTrials.gov.