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NCT04285723 · ClinicalTrials.gov registry record
Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 57
- Enrollment target
NCT04285723: Completed study, sponsored by Novartis Pharmaceuticals.
NCT04285723 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04285723 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 57 participants
- Enrollment target
Study Summary
The study was a site-based retrospective non-interventional medical chart review of pediatric and adult male and female patients with PIK3CA-Related Overgrowth Spectrum (PROS) who initiated alpelisib at least 24 weeks before the cut-off date at a MAP site. The study cut-off date was 09-Mar-2020. Patient-level data were abstracted from medical charts of all eligible patients at all participating sites. Study completion date refers to the last date data was extracted. Information from patients treated with alpelisib was used to describe the efficacy and safety of alpelisib in PROS patients.
Primary Outcome
Response is defined by achieving at least 20% reduction from index date in the sum of measurable target lesion volume (1 to 3 lesions, via central review of imaging scans), provided that none of the individual target lesions have ≥ 20% increase from index date and in absence of progression of non-target lesions and without new lesions.
Interventions
- OTHER alpelisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-06-09 |
| Est. Completion | 2021-04-16 |
What the finished NCT04285723 record still lists
NCT04285723 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 57 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which alpelisib is the first listed.
NCT04285723 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04285723 about?
NCT04285723 is a clinical study titled "Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib". The study was a site-based retrospective non-interventional medical chart review of pediatric and adult male and female patients with PIK3CA-Related Overgrowth Spectrum (PROS) who initiated alpelisib at least 24 weeks before the cut-off date at a MAP site. The study cut-off date was 09-Mar-2020. Pa...
What is the current status of trial NCT04285723?
This trial is currently completed. The enrollment target is 57 participants. The study started on 2020-06-09. Estimated completion is 2021-04-16.
What interventions are being tested in trial NCT04285723?
The interventions under investigation include: alpelisib (OTHER).
Who is sponsoring clinical trial NCT04285723?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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