deltatrials
Active Not Recruiting PHASE2 INTERVENTIONAL 1-arm NCT04980833

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

Interventions Alpelisib
Updated 16 times since 2021 Last updated: Jan 30, 2026 Started: Jan 27, 2022 Primary completion: Jul 22, 2027 Completion: Jul 22, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Feb 2022 · 2 months · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Jun 2022 · 3 months · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Sep 2023 · 10 months · monthly snapshot~Sep 2023 – ~Apr 2024 · 7 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Sep 2025 · 10 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Feb 2026 · 4 months · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshot

Change History

16 versions recorded
  1. Feb 2026 — Present [monthly]

    Active Not Recruiting PHASE2

  2. Oct 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE2

  3. Sep 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Nov 2024 — Sep 2025 [monthly]

    Active Not Recruiting PHASE2

  5. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE2

Show 11 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

  2. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

  3. Sep 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE2

  4. Nov 2022 — Sep 2023 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  5. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE2

  6. Jun 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  7. Mar 2022 — Jun 2022 [monthly]

    Recruiting PHASE2

  8. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  9. Dec 2021 — Feb 2022 [monthly]

    Not Yet Recruiting PHASE2

  10. Nov 2021 — Dec 2021 [monthly]

    Not Yet Recruiting PHASE2

  11. Sep 2021 — Nov 2021 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .