drugset / Trial / NCT02155088

BYL719 in Combination With Gemcitabine and (Nab)-Paclitaxel in Locally Advanced and Metastatic Pancreatic Cancer

NCT02155088

NaSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to see primarily if BYL719 is safe to be given to patients in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel is an FDA-approved regimen to treat pancreatic cancer. Secondary goals will be to find out the effect on tumor of this new drug combination of BYL719, gemcitabine and nab-paclitaxel. In the first part of the study, different doses of BYL719 will be tested. In the second part of the study, all patients will be started at the same dose of BYL719.

Timeline

Start
2014-10-30
Primary completion
2016-12-01
Completion
2020-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpelisib Small molecule 250 mg
Subject Gemcitabine Small molecule 800 mg/m2
Subject Paclitaxel Small molecule 125 mg/m2