EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS) (NCT06997588)
Study Assessing the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
π©Ί Plain-English Summary (8th-Grade Level)
This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).
Who can join: Review the eligibility criteria below.
Location: Washington University β St Louis, Missouri
Age range: 2 Years to 100 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- Washington University β St Louis, Missouri
- UNC Chapel Hill β Chapel Hill, North Carolina
- Cinn Children Hosp Medical Center β Cincinnati, Ohio
- Oregon Health Sciences University β Portland, Oregon
- Childrens Hosp Pittsburgh UPMC β Pittsburgh, Pennsylvania
- Baylor College Of Medicine β Houston, Texas
- UT Health Science Center β Houston, Texas
- Childrens Hospital and Regional Medical Center β Seattle, Washington
- Novartis Investigative Site β Sydney, New South Wales
- Novartis Investigative Site β Sydney, New South Wales
- Novartis Investigative Site β North Adelaide, South Australia
- Novartis Investigative Site β Salzburg,
- Novartis Investigative Site β Vienna,
- Novartis Investigative Site β Ghent,
- Novartis Investigative Site β Angers,
- Novartis Investigative Site β Bron,
- Novartis Investigative Site β Dijon,
- Novartis Investigative Site β Montpellier,
- Novartis Investigative Site β Paris,
- Novartis Investigative Site β Toulouse,
- Novartis Investigative Site β Tours,
- Novartis Investigative Site β Freiburg im Breisgau, Baden-Wurttemberg
- Novartis Investigative Site β DΓΌsseldorf, North Rhine-Westphalia
- Novartis Investigative Site β Leipzig, Saxony
- Novartis Investigative Site β Halle, Saxony-Anhalt
π Contact the Study Coordinator
Phone: (888) 669-6682
Email: novartis.email@novartis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in PIK3CA-related Overgrowth Spectrum (PROS)
- Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1) β Boston, Massachusetts
- Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum β San Francisco, California
- A Phase 2 Study of Mutant-selective PI3KΞ± Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study) β Phoenix, Arizona
Explore by condition: All PIK3CA-related Overgrowth Spectrum (PROS) clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.