NCT03941782

Compassionate Use of BYL 719 Alpelisib

INST UNM 1601: Compassionate Use of BYL 719 Alpelisib

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This is a compassionate use protocol of BYL719 (alpelisib) treatment for a single patient with locally advanced lymphangioma positive PI3K alpha H1047R mutation.

Detailed description

As a single agent, alpelisib will be administered at a starting dose of 350 mg orally once daily on a continuous dosing schedule and can be adjusted for toxicity per the recommendations in this protocol. No pretreatment will be given prior to the medication. We plan on treating this individual patient for a tentative period of 12 weeks at which time treating physician will reevaluate the patient's clinical and radiological response and further duration of treatment will be contingent on that assessment.

Conditions

• Lymphangioma

Interventions

Type	Name	Description
DRUG	Alpelisib	As a single agent, alpelisib will be administered at a starting dose of 350 mg orally once daily on a continuous dosing schedule and can be adjusted for toxicity per the recommendations in this protocol. No pretreatment will be given prior to the medication.

Timeline

• First posted: 2019-05-08
• Last updated: 2024-01-11

Locations

1 site across 1 country: United States