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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)

Study acronym: EPIK-P3
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion moved earlier from Aug 20, 2027 to Jun 22, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Study description shortened, about 31 words
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Jul 22, 2027 to Aug 20, 2027v17
  3. Site details revised at 1 of 6 sitesv16
  4. Primary completion date: Aug 5, 2027 to Jul 22, 2027
    • Study completion date: Sep 1, 2027 to Jul 22, 2027
    • Study sites revised (6)
    v15
  5. Site details revised at 1 of 6 sitesv14
Show 12 earlier versionsHide 12 earlier versions
  1. Enrollment target: 49 to 41
    • Primary completion date: Jul 26, 2027 to Aug 5, 2027
    • Study completion date: Aug 23, 2027 to Sep 1, 2027
    v13
  2. Enrollment target: 39 to 49
    • Primary completion date: Aug 13, 2027 to Jul 26, 2027
    • Study completion date: Sep 10, 2027 to Aug 23, 2027
    • Study sites revised (6)
    v12
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 39
    • Site details revised at 6 of 6 sites
    v11
  4. Primary completion date: Aug 25, 2027 to Aug 13, 2027
    • Study completion date: Sep 22, 2027 to Sep 10, 2027
    • Site details revised at 4 of 6 sites
    v10
  5. Study sites: 5 to 6
    • Primary completion date: Apr 29, 2027 to Aug 25, 2027
    • Study completion date: May 27, 2027 to Sep 22, 2027
    v9
  6. Study sites: 4 to 5
    • Primary completion date: Jul 5, 2027 to Apr 29, 2027
    • Study completion date: Aug 2, 2027 to May 27, 2027
    v8
  7. Study sites: 3 to 4v7
  8. Start date changed from estimate of Feb 1, 2022 to Jan 27, 2022v6
  9. Study sites: 2 to 3
    • Primary completion date: May 20, 2027 to Jul 5, 2027
    • Study completion date: Jun 17, 2027 to Aug 2, 2027
    v5
  10. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date: Dec 15, 2021 to Feb 1, 2022
    • Study sites: 0 to 2
    • Primary completion date: May 18, 2027 to May 20, 2027
    • Study completion date: Jun 15, 2027 to Jun 17, 2027
  11. Primary completion date: Apr 28, 2027 to May 18, 2027
    • Study completion date: May 26, 2027 to Jun 15, 2027
    • Start date: Nov 25, 2021 to Dec 15, 2021
    v3
  12. Start date: Sep 30, 2021 to Nov 25, 2021
    • Primary completion date: Oct 27, 2027 to Apr 28, 2027
    • Study completion date: Oct 27, 2027 to May 26, 2027
    v2
  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 34 trials at risk
This Phase II, multicenter, open-label study, preceded by a retrospective non-interventional period, is assessing the long-term safety and efficacy of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth spectrum (PROS).
Trial Details
NCT Number NCT04980833
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 PIK3CA-related Overgrowth Spectrum (PROS)
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov