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NCT06997588 · ClinicalTrials.gov registry record · Phase 2

EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

A Phase 2 study of PIK3CA-related Overgrowth Spectrum (PROS), sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 2
Development phase
104
Enrollment target
20
Study locations

NCT06997588 is a Phase 2 study of PIK3CA-related Overgrowth Spectrum (PROS) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 104 participants, below the 175-participant average among 3 other PIK3CA-related Overgrowth Spectrum (PROS) trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT06997588, a Phase 2 study of PIK3CA-related Overgrowth Spectrum (PROS), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 2
Development phase
104 participants
Enrollment target
20
Study locations

Study Summary

This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).

Conditions Studied

PIK3CA-related Overgrowth Spectrum (PROS)

Interventions

  • DRUG Alpelisib

Study Locations (20)

Other

  • Novartis Investigative Site - Salzburg
  • Novartis Investigative Site - Vienna
  • Novartis Investigative Site - Ghent
  • Novartis Investigative Site - Angers
  • Novartis Investigative Site - Bron
  • Novartis Investigative Site - Dijon
  • Novartis Investigative Site - Montpellier
  • Novartis Investigative Site - Paris
  • Novartis Investigative Site - Tours
  • Novartis Investigative Site - Berlin

New South Wales

  • Novartis Investigative Site - Sydney
  • Novartis Investigative Site - Sydney

Missouri

  • Washington University - St Louis

South Australia

  • Novartis Investigative Site - North Adelaide

Baden-Wurttemberg

  • Novartis Investigative Site - Freiburg im Breisgau

North Rhine-Westphalia

  • Novartis Investigative Site - Düsseldorf

Saxony

  • Novartis Investigative Site - Leipzig

Saxony-Anhalt

  • Novartis Investigative Site - Halle

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2025-10-09
Est. Completion 2030-09-30
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06997588

The ClinicalTrials.gov registry entry for NCT06997588 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 175-participant average among 3 other PIK3CA-related Overgrowth Spectrum (PROS) trials with a reported enrollment target (41% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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.

NCT06997588 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, New South Wales, Missouri.

Frequently Asked Questions

What is clinical trial NCT06997588 about?

NCT06997588 is a clinical study titled "EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)". This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).

What is the current status of trial NCT06997588?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2025-10-09. Estimated completion is 2030-09-30.

What conditions does trial NCT06997588 study?

This clinical trial studies the following conditions: PIK3CA-related Overgrowth Spectrum (PROS).

What interventions are being tested in trial NCT06997588?

The interventions under investigation include: Alpelisib (DRUG).

Who is sponsoring clinical trial NCT06997588?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06997588 being conducted?

This trial has 20 study locations across Missouri, New South Wales, South Australia, Baden-Wurttemberg, North Rhine-Westphalia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.