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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)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Aug 2, 2028 → Jan 29, 2029
See other at-risk trials from Novartis

Record History

  1. Re-verified, no change to tracked fields
  2. Primary completion pushed from Aug 2, 2028 to Jan 29, 2029 Enrollment increased: 104 → 140 participants · Completion pushed from Sep 30, 2030 to Jun 18, 2031 · Secondary endpoints: 17 to 18 · 3 more Show 6 more changesShow less
    • Enrollment increased: 104 → 140 participants
    • Completion pushed from Sep 30, 2030 to Jun 18, 2031
    • Secondary endpoints: 17 to 18
    • Study description shortened, about 8 words
    • Site contacts updated at 1 of 39 sites
    • Eligibility criteria expanded, about 1 word
  3. Study sites: 38 to 39 Eligibility criteria expanded, about 14 words · Secondary endpoints: details revised at 12 of 17 entries · Study description expanded, about 2 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 12 of 17 entries
    • Study description expanded, about 2 words
  4. Study sites: 37 to 38v24
  5. Study sites: 35 to 37v23
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 33 to 35v22
  2. Study sites: 32 to 33v21
  3. Re-verified, no change to tracked fieldsv20
  4. Study sites: 30 to 32v19
  5. Study sites: 29 to 30v18
  6. Study sites: 28 to 29v17
  7. Study sites: 27 to 28v16
  8. Re-verified, no change to tracked fieldsv15
  1. Trial sites expanded: 22 → 27 locationsv14
  2. Site details revised at 4 of 22 sitesv13
  3. Study sites: 20 to 22v12
  4. Study sites: 19 to 20v11
  5. Re-verified, no change to tracked fieldsv10
  6. Study sites: 18 to 19v9
  7. Study sites: 16 to 18v8
  8. Study sites: 6 to 16v7
  9. Study sites: 4 to 6v6
  10. Study sites: 3 to 4v5
  11. Study sites: 2 to 3v4
  12. Study sites: 1 to 2v3
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Oct 21, 2025 to Oct 9, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 21, 2025 to Oct 9, 2025
  14. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novartis
555 trials monitored
See 31 trials at risk
This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).
Trial Details
NCT Number NCT06997588
Lead Sponsor Novartis Pharmaceuticals
Conditions PIK3CA-related Overgrowth Spectrum (PROS)
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov