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NCT04980833 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of PIK3CA-related Overgrowth Spectrum (PROS), sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 6
- Study locations
NCT04980833: Active Phase 2 study of PIK3CA-related Overgrowth Spectrum (PROS), sponsored by Novartis Pharmaceuticals.
NCT04980833 is a Phase 2 study of PIK3CA-related Overgrowth Spectrum (PROS) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 41 participants, below the 196-participant average among 3 other PIK3CA-related Overgrowth Spectrum (PROS) trials with a reported enrollment target (79% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04980833, a Phase 2 study of PIK3CA-related Overgrowth Spectrum (PROS), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a prospective interventional Phase II multi center study, open label, preceded by a retrospective non-interventional period, to assess the long-term safety and efficacy of alpelisib, in pediatric and adult participants with PROS.
Primary Outcome
Incidence of new or worsening grade ≥3 treatment emergent AEs (by system organ class and preferred term)
Conditions Studied
Interventions
- DRUG Alpelisib
Study Locations (6)
Other
- Novartis Investigative Site - Dijon
- Novartis Investigative Site - Montpellier
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Dublin
- Novartis Investigative Site - Madrid
Massachusetts
- Boston Childrens Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2027-07-22 |
| Phase | Phase 2 |
What the registry record for NCT04980833 still lists
NCT04980833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 196-participant average among 3 other PIK3CA-related Overgrowth Spectrum (PROS) trials with a reported enrollment target (79% lower).
The record links to 1 condition, with PIK3CA-related Overgrowth Spectrum (PROS) appearing as the primary indexed condition, and to 1 intervention - of which Alpelisib is the first listed.
NCT04980833 lists 6 locations in 2 states (Other, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04980833 about?
NCT04980833 is a clinical study titled "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)". This is a prospective interventional Phase II multi center study, open label, preceded by a retrospective non-interventional period, to assess the long-term safety and efficacy of alpelisib, in pediatric and adult participants with PROS.
What is the current status of trial NCT04980833?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2022-01-27. Estimated completion is 2027-07-22.
What conditions does trial NCT04980833 study?
This clinical trial studies the following conditions: PIK3CA-related Overgrowth Spectrum (PROS).
What interventions are being tested in trial NCT04980833?
The interventions under investigation include: Alpelisib (DRUG).
Who is sponsoring clinical trial NCT04980833?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04980833 being conducted?
This trial has 6 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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