Trials / Conditions / PIK3CA-Related Overgrowth Spectrum (PROS)

PIK3CA-Related Overgrowth Spectrum (PROS)

9 registered clinical trials studyying PIK3CA-Related Overgrowth Spectrum (PROS) — 3 currently recruiting.

Status	Trial	Sponsor	Phase
Recruiting	EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) NCT06997588	Novartis Pharmaceuticals	Phase 2
Recruiting	A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Over NCT06789913	Relay Therapeutics, Inc.	Phase 2
Recruiting	Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Patients Wit NCT06975618	Haihe Biopharma Co., Ltd.	Phase 1 / Phase 2
Active Not Recruiting	Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum NCT04980833	Novartis Pharmaceuticals	Phase 2
Active Not Recruiting	Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA- NCT04589650	Novartis Pharmaceuticals	Phase 2
Completed	Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelis NCT04285723	Novartis Pharmaceuticals	—
Completed	Study of Sirolimus Therapy for Segmental Overgrowth Caused by Somatic PI3K Activation NCT02428296	National Human Genome Research Institute (NHGRI)	Phase 2
Available	Managed Access Programs for BYL719, Alpelisib NCT04085653	Novartis Pharmaceuticals	—
No Longer Available	Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies NCT03317366	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)	—