Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (NCT04589650)
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)
π©Ί Plain-English Summary (8th-Grade Level)
This is a prospective Phase II multi-center study with an initial 16-week, randomized, double-blind, placebo-controlled period, followed by two extension periods to assess the efficacy, safety and pharmacokinetics (PK) of alpelisib in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)
Who can join: Review the eligibility criteria below.
Location: UCSF Birthmarks and Vascular Center β San Francisco, California
Age range: 0 Days 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 (36 Sites)
Showing the first 25 of 36 sites.
- UCSF Birthmarks and Vascular Center β San Francisco, California
- Childrens Hospital Colorado β Aurora, Colorado
- Washington Univ School Of Medicine β St Louis, Missouri
- Fink Childrens Ambulatory Care Ctr β New York, New York
- UNC Chapel Hill β Chapel Hill, North Carolina
- Cincinnati Children s Hospital Medical Center β Cincinnati, Ohio
- Cinn Children Hosp Medical Center β Cincinnati, Ohio
- CHOP Abramson Pediatric Resch Ctr β Philadelphia, Pennsylvania
- Unv of TX Southwestern Medical Center β Dallas, Texas
- Baylor College Of Medicine β Houston, Texas
- Childrens Hospital and Regional Medical Center β Seattle, Washington
- Novartis Investigative Site β Montreal, Quebec
- Novartis Investigative Site β Montreal, Quebec
- Novartis Investigative Site β Beijing,
- Novartis Investigative Site β Shanghai,
- Novartis Investigative Site β Bordeaux,
- Novartis Investigative Site β Dijon,
- Novartis Investigative Site β Paris,
- 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 Hamburg,
- Novartis Investigative Site β Heidelberg,
- Novartis Investigative Site β Hong Kong,
π Contact the Study Coordinator
Phone: (877) 827-3222
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
- 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) β St Louis, Missouri
- 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.