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) (EPIK-P3)
A Phase II Study to Evaluate the Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)
Sponsor: Novartis Pharmaceuticals
Listed as NCT04980833, this PHASE2 trial focuses on PIK3CA-related Overgrowth Spectrum (PROS) and remains ongoing. Sponsored by Novartis Pharmaceuticals, it has been updated 16 times since 2022, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
16 versions recorded-
Feb 2026 — Present [monthly]
Active Not Recruiting PHASE2
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Oct 2025 — Feb 2026 [monthly]
Active Not Recruiting PHASE2
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Sep 2025 — Oct 2025 [monthly]
Active Not Recruiting PHASE2
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Nov 2024 — Sep 2025 [monthly]
Active Not Recruiting PHASE2
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Sep 2024 — Nov 2024 [monthly]
Active Not Recruiting PHASE2
▶ Show 11 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
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Apr 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
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Sep 2023 — Apr 2024 [monthly]
Active Not Recruiting PHASE2
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Nov 2022 — Sep 2023 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Sep 2022 — Nov 2022 [monthly]
Recruiting PHASE2
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Jun 2022 — Sep 2022 [monthly]
Recruiting PHASE2
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Mar 2022 — Jun 2022 [monthly]
Recruiting PHASE2
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Feb 2022 — Mar 2022 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Dec 2021 — Feb 2022 [monthly]
Not Yet Recruiting PHASE2
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Nov 2021 — Dec 2021 [monthly]
Not Yet Recruiting PHASE2
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Sep 2021 — Nov 2021 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .