drugset / Trial / NCT01822613

Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

NCT01822613

Phase 1 Completed 48 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.

Timeline

Start
2013-07-26
Primary completion
2016-06-03
Completion
2016-06-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpelisib Small molecule 200 mg Oral
Subject Alpelisib Small molecule 400 mg Oral
Comparator Docetaxel Small molecule
Subject ELGEMTUMAB Monoclonal antibody 10 mg/kg
Subject ELGEMTUMAB Monoclonal antibody 40 mg/kg
Comparator Irinotecan Small molecule
Comparator Paclitaxel Small molecule