Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

NCT05948943 · View on ClinicalTrials.gov ↗

Study Summary

The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the change in radiological response and symptom severity upon treatment with alpelisib film-coated tablets (FCT) as compared to placebo.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Alpelisib

Study Locations (20)

Other

  • Novartis Investigative Site — Capital Federal
  • Novartis Investigative Site — Brussels
  • Novartis Investigative Site — Bordeaux
  • Novartis Investigative Site — Bron

Ohio

  • Cinn Children Hosp Medical Center — Cincinnati
  • Univ Hospital Of Cleveland — Cleveland
  • Cleveland Clinic Foundation — Cleveland

California

  • UCSF Benioff Children s Hospital — Oakland
  • Lucile Packard Childrens Hosp — Palo Alto

Texas

  • Baylor College Of Medicine — Houston
  • U of TX Health Science Ct — Houston

New South Wales

  • Novartis Investigative Site — Sydney
  • Novartis Investigative Site — Sydney

District of Columbia

  • Childrens National Medical Center — Washington D.C.

Massachusetts

  • Childrens Hosp Boston Dept of Heme — Boston

Missouri

  • WA Uni School Of Med — St Louis

Trial Details

FieldValue
Enrollment Target 232 participants
Start Date 2023-11-24
Est. Completion 2033-05-02
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05948943

The ClinicalTrials.gov registry entry for NCT05948943 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Lymphatic Malformations appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05948943 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05948943 about?

NCT05948943 is a clinical study titled "Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.". The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the change in radiological response and symptom severity upon treatment with alpelisib film-coated tablets (FCT) as compared to placebo.

What is the current status of trial NCT05948943?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 232 participants. The study started on 2023-11-24. Estimated completion is 2033-05-02.

What conditions does trial NCT05948943 study?

This clinical trial studies the following conditions: Lymphatic Malformations. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05948943?

The interventions under investigation include: Placebo (DRUG), Alpelisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05948943?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05948943 being conducted?

This trial has 20 study locations across California, District of Columbia, Massachusetts, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial