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Clinical Trials and Novel Therapies Alpelisib in Pediatric and Adult Patients with Lymphatic Malformations Associated with a PIK3CA Mutation (EPIK-L1)

<p>Alpelisib in Pediatric and Adult Patients with Lymphatic Malformations Associated with a PIK3CA Mutation (EPIK-L1)</p>

Description

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.

Eligibility

  • Ages: 0 to 65 years
  • Confirmed diagnosis of lymphatic malformation with PIK3CA mutation
  • ECOG performance status 0–2
  • Adequate organ function
  • No prior treatment with Alpelisib

Detailed inclusion and exclusion criteria are listed at clinicaltrials.gov.

Contact

Ionela Iacobas, MD

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