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NCT05948943 · ClinicalTrials.gov registry record · Phase 2
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
A Phase 2 study of Lymphatic Malformations, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 232
- Enrollment target
- 20
- Study locations
NCT05948943 is a Phase 2 study of Lymphatic Malformations that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 232 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT05948943, a Phase 2 study of Lymphatic Malformations, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 232 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2023-11-24 |
| Est. Completion | 2033-05-02 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. 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 1,375 total studies on file at ClinicalTrials.gov.
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.
NCT05948943 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Ohio, California.
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.
What interventions are being tested in trial NCT05948943?
The interventions under investigation include: Placebo (DRUG), Alpelisib (DRUG).
Who is sponsoring clinical trial NCT05948943?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
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