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Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.

Study acronym: EPIK-RO
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Jun 27, 2031 → Mar 23, 2032
See other at-risk trials from Novartis

Record History

  1. Primary completion pushed from Jun 27, 2031 to Mar 23, 2032 Completion pushed from Jul 25, 2031 to Apr 20, 2032 · Start date: Jan 1, 2027 to Dec 15, 2026 · Eligibility criteria expanded, about 10 words · 1 more Show 4 more changesShow less
    • Completion pushed from Jul 25, 2031 to Apr 20, 2032
    • Start date: Jan 1, 2027 to Dec 15, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
Breast Cancer
5,213 trials monitored
See 271 trials at risk
The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.
Trial Details
NCT Number NCT07679269
Lead Sponsor Novartis Pharmaceuticals
Conditions PIK3CA-Related Overgrowth Spectrum (PROS), Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation)
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov