Australian & New Zealand Childrens Haematology/Oncology Group
Study Title
A Two-stage Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
Protocol ID
CBYL719P12201
Disease (Sub Disease)
Lymphatic Malformations
Diagnosis Stage
Newly diagnosed
Relapsed/Refractory
Relapsed/Refractory
Location
QLD
Sponsor
Novartis Pharmaceuticals
Links
Trial Status
Open
Sites
Queensland Children's Hospital
Study Type
Treatment
Phase
Phase 1/2
Age Eligibility
2 Years and older
International registry ID's
NCT05948943
| Study Title | A Two-stage Double-blind Randomized Placebo-controlled Study to Assess the Efficacy Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation. |
|---|---|
| Protocol ID | CBYL719P12201 |
| Disease (Sub Disease) | Lymphatic Malformations |
| Diagnosis Stage | Newly diagnosed Relapsed/Refractory |
| Location | QLD |
| Sponsor | Novartis Pharmaceuticals |
| Links | https://clinicaltrials.gov/study/NCT05948943 |
| Trial Status | Open |
| Trial Open Date | 24/11/2023 |
| Sites | Queensland Children's Hospital |
| Study Type | Treatment |
| Phase | Phase 1/2 |
| Age Eligibility | 2 Years and older |
| International registry ID's | NCT05948943 |