alpelisib
alpelisib: developed by 1 company · 29 clinical trials tracked · 3 FDA decisions.
alpelisib evidence translation
What we can confirm
3 FDA records · 29 tracked trials
What it means
What to watch
Prepared research question
How could alpelisib → NVS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 7 study sponsors
Related indications
Development Pipeline (2)
| Company | Phase |
|---|---|
| Novartis AG (NVS) Advanced HER2+Breast Cancer; PIK3CA-Related Overgrowth Spect… | Phase 4 |
| Novartis AG (NVS) | Approved |
Clinical Trials (29)showing 10 most recent
Managed Access Programs for BYL719, Alpelisib
An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.
Primary endpoint: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study Assessing the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
Primary endpoint: Proportion of participants with a confirmed objective response by BIRC
VATCH (Vascular Anomaly Analysis for Therapy Choice): Phase II Study of Alpelisib Treatment in Subjects With TIE2/PIK3CA Pathway Driven Vascular Anomalies
Primary endpoint: Percentage of subjects with a Substantial Response or Intermediate Response to Alpelisib using an Individualized Response Criteria
A Modular Open Label, Signal Seeking, Phase II Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations (TARGET-VM)
Primary endpoint: The number of participants who achieve or exceed a predetermined threshold of improvement in their most significant symptom at 48 weeks based on the Vascular Malformation Patient Specific Outcome Measure (VM-PSOM).
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.
Primary endpoint: Stage 2:Radiological response rate at Week 24 of Stage 2 (adult and pediatric (6 - 17 years of age) participants)
Molecular Analysis for Combination Therapy Choice (ComboMATCH)
Primary endpoint: Accrual of patients to ComboMATCH treatment trials
An Umbrella, Randomized, Controlled, Pre Operative Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer
Primary endpoint: Percentage Change in Ki67
A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Primary endpoint: Number of Participants with DLTs Observed During the First Cycle
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy
Primary endpoint: Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
FDA Decisions3 records
Frequently asked questions
Who is developing alpelisib?
alpelisib is being developed by Novartis AG.
How many clinical trials involve alpelisib?
BioSniper tracks 29 clinical trials involving alpelisib.
What is alpelisib's latest FDA decision?
The most recent tracked FDA decision for alpelisib is Approval, dated April 24, 2024.