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

Study acronym: EPIK-P2
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 206 → 236 participants Eligibility criteria expanded, about 33 words · Secondary endpoints: details revised at 17 of 22 entries · Study sites revised (36) · 2 more Show 5 more changesShow less
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 17 of 22 entries
    • Study sites revised (36)
    • Publications: details revised at 2 of 2 entries
    • Study description expanded, about 2 words
  2. Site details revised at 3 of 36 sitesv39
  3. Site details revised at 1 of 36 sitesv38
  4. Re-verified, no change to tracked fieldsv37
  5. Enrollment target: 203 to 206 Completion date: Jan 17, 2031 to Jan 9, 2031 · Site details revised at 2 of 36 sitesv36 Show 2 more changesShow less
    • Completion date: Jan 17, 2031 to Jan 9, 2031
    • Site details revised at 2 of 36 sites
Show 34 earlier versionsHide 34 earlier versions
  1. Enrollment target: 200 to 203 Site details revised at 1 of 36 sitesv35 Show 1 more changeShow less
    • Site details revised at 1 of 36 sites
  2. Enrollment target: 205 to 200 Completion date: Feb 28, 2031 to Jan 17, 2031 · Study description expanded, about 557 words · Study sites revised (36)v34 Show 3 more changesShow less
    • Completion date: Feb 28, 2031 to Jan 17, 2031
    • Study description expanded, about 557 words
    • Study sites revised (36)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 35 to 36v33
  4. Study sites: 36 to 35 Completion date: Feb 21, 2031 to Feb 28, 2031v32 Show 1 more changeShow less
    • Completion date: Feb 21, 2031 to Feb 28, 2031
  5. Completion date: Feb 14, 2031 to Feb 21, 2031 Site details revised at 1 of 36 sitesv31 Show 1 more changeShow less
    • Site details revised at 1 of 36 sites
  6. Enrollment target: 188 to 205 Site details revised at 5 of 36 sitesv30 Show 1 more changeShow less
    • Site details revised at 5 of 36 sites
  7. Results first posted: Feb 10, 2025 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 205 to confirmed 188 · Study sites: 39 to 36 · 4 morev29 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 205 to confirmed 188
    • Study sites: 39 to 36
    • Completion date: Apr 28, 2031 to Feb 14, 2031
    • Secondary endpoints revised (22)
    • Primary endpoint revised
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  8. Eligibility criteria expanded, about 240 words Secondary endpoints revised (22) · Study description expanded, about 52 words · Study sites revised (39)v28 Show 3 more changesShow less
    • Secondary endpoints revised (22)
    • Study description expanded, about 52 words
    • Study sites revised (39)

    See this version in full on ClinicalTrials.gov ↗

  9. Site details revised at 2 of 39 sitesv27
  10. Enrollment target: 189 to 205 Completion date: Mar 27, 2031 to Apr 28, 2031 · Site details revised at 1 of 39 sitesv26 Show 2 more changesShow less
    • Completion date: Mar 27, 2031 to Apr 28, 2031
    • Site details revised at 1 of 39 sites
  11. Study sites revised (39)v25 See this version in full on ClinicalTrials.gov ↗
  12. Completion date: Mar 11, 2031 to Mar 27, 2031 Study sites revised (39)v24 Show 1 more changeShow less
    • Study sites revised (39)

    See this version in full on ClinicalTrials.gov ↗

  13. Primary completion date changed from estimate of Jun 7, 2030 to Mar 20, 2024 Completion date: Jun 7, 2030 to Mar 11, 2031 · Study sites revised (39)v23 Show 2 more changesShow less
    • Completion date: Jun 7, 2030 to Mar 11, 2031
    • Study sites revised (39)

    See this version in full on ClinicalTrials.gov ↗

  14. Site details revised at 3 of 39 sitesv22
  15. Study sites revised (39)v21 See this version in full on ClinicalTrials.gov ↗
  16. Study description revised Study sites revised (39)v20 Show 1 more changeShow less
    • Study sites revised (39)

    See this version in full on ClinicalTrials.gov ↗

  17. Primary completion date: Sep 20, 2023 to Jun 7, 2030 Completion date: Feb 25, 2030 to Jun 7, 2030v19 Show 1 more changeShow less
    • Completion date: Feb 25, 2030 to Jun 7, 2030
  18. Study sites revised (39)v18 See this version in full on ClinicalTrials.gov ↗
  19. Primary completion date: Jun 8, 2023 to Sep 20, 2023v17
  20. Eligibility criteria expanded, about 75 words Site details revised at 3 of 39 sitesv16 Show 1 more changeShow less
    • Site details revised at 3 of 39 sites

    See this version in full on ClinicalTrials.gov ↗

  21. Primary endpoint revised Enrollment target: 174 to 189 · Study sites: 33 to 39 · Primary completion date: Mar 27, 2023 to Jun 8, 2023 · 5 morev15 Show 8 more changesShow less
    • Enrollment target: 174 to 189
    • Study sites: 33 to 39
    • Primary completion date: Mar 27, 2023 to Jun 8, 2023
    • Completion date: Dec 26, 2029 to Feb 25, 2030
    • Secondary endpoints: 20 to 22
    • Study description expanded, about 27 words
    • Study arms: 6 to 7
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  22. Re-verified, no change to tracked fieldsv14
  23. Study sites: 31 to 33v13
  24. Site contacts updated at 1 of 31 sitesv12
  25. Study sites: 30 to 31v11
  26. Enrollment target: 150 to 174 Study sites: 26 to 30v10 Show 1 more changeShow less
    • Study sites: 26 to 30
  27. Study sites: 25 to 26 Eligibility criteria expanded, about 135 words · Secondary endpoints: 19 to 20 · Study description expanded, about 58 words · 1 morev9 Show 4 more changesShow less
    • Eligibility criteria expanded, about 135 words
    • Secondary endpoints: 19 to 20
    • Study description expanded, about 58 words
    • Study arms: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  28. Study sites: 21 to 25v8
  29. Study sites: 15 to 21v7
  30. Study sites: 9 to 15v6
  31. Study sites: 4 to 9v5
  32. Study sites: 2 to 4v4
  33. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Mar 31, 2021 to Apr 19, 2021v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 31, 2021 to Apr 19, 2021
  34. Start date: Feb 2, 2021 to Mar 31, 2021 Primary completion date: Jan 27, 2023 to Mar 27, 2023v2 Show 1 more changeShow less
    • Primary completion date: Jan 27, 2023 to Mar 27, 2023
  1. 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 is a prospective Phase II multi-center study with an initial 16-week, randomized, double-blind, placebo-controlled period, followed by two extension periods to assess the efficacy, safety and pharmacokinetics (PK) of alpelisib in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)
Trial Details
NCT Number NCT04589650
Lead Sponsor Novartis Pharmaceuticals
Conditions PIK3CA-related Overgrowth Spectrum (PROS)
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov