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ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:32 AM EDT

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Showing 1–10 of 10 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: PIK3CA-Related Overgrowth Spectrum (PROS) Clear all
Active, not recruiting Phase 2 Interventional

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)

NCT04980833
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years to 100 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 14, 2026 · Synced Oct 17, 2026, 4:32 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)

NCT03094832
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome
Interventions
Miransertib
Drug
Lead sponsor
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Industry
Eligibility
2 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
6
States / cities
Atlanta, Georgia • Chicago, Illinois • Boston, Massachusetts + 3 more
Source: ClinicalTrials.gov public record
Updated Apr 13, 2023 · Synced Oct 17, 2026, 4:32 AM EDT
Active, not recruiting Phase 2 Interventional

A Study of the Safety and Tolerability in Participants With PIK3CA-related Overgrowth Spectrum or Proteus Syndrome Who Are Being Treated With Miransertib (MK-7075) in Other Studies (MK-7075-006)

NCT04980872
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)
Interventions
Miransertib
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
2 Years to 120 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2030
U.S. locations
5
States / cities
Atlanta, Georgia • Boston, Massachusetts • Cincinnati, Ohio + 2 more
Source: ClinicalTrials.gov public record
Updated Feb 7, 2025 · Synced Oct 17, 2026, 4:32 AM EDT
Recruiting Phase 2 Interventional

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
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years to 100 Years
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
9
States / cities
St Louis, Missouri • Chapel Hill, North Carolina • Cincinnati, Ohio + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 9, 2026 · Synced Oct 17, 2026, 4:32 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum

NCT04589650
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
0 Days to 100 Years
Enrollment
236 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2031
U.S. locations
11
States / cities
San Francisco, California • Aurora, Colorado • St Louis, Missouri + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 7, 2026 · Synced Oct 17, 2026, 4:32 AM EDT
Completed No phase listed Observational Results available

Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib

NCT04285723
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum (PROS)
Interventions
alpelisib
Other
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years and older
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 9, 2023 · Synced Oct 17, 2026, 4:32 AM EDT
Completed No phase listed Observational

Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study

NCT05294289
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum
Interventions
Alpelisib
Other
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
5 Years to 99 Years
Enrollment
77 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 24, 2025 · Synced Oct 17, 2026, 4:32 AM EDT
Completed Phase 2 Interventional Results available

Study of Sirolimus Therapy for Segmental Overgrowth Caused by Somatic PI3K Activation

NCT02428296
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum (PROS), Growth Disorder, Genetics
Interventions
Sirolimus
Drug
Lead sponsor
National Human Genome Research Institute (NHGRI)
NIH
Eligibility
3 Years to 65 Years
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Feb 5, 2020 · Synced Oct 17, 2026, 4:32 AM EDT
Completed No phase listed Observational

A Study of the Epidemiology and Hospital Management of Patients With PROS in France

NCT07222423
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years and older
Enrollment
3,605 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Oct 29, 2025 · Synced Oct 17, 2026, 4:32 AM EDT
Recruiting Phase 2 Interventional

A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)

NCT06789913
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations, Vascular Malformations, PIK3CA Mutation, CLOVES Syndrome, Klippel Trenaunay Syndrome, Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP), Vascular Anomalies
Interventions
RLY-2608, Placebo
Drug
Lead sponsor
Relay Therapeutics, Inc.
Industry
Eligibility
2 Years and older
Enrollment
277 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
22
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Los Angeles, California + 19 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Oct 17, 2026, 4:32 AM EDT