NCT02155088

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

A Phase I Trial With Cohort Expansion of BYL719 in Combination With Gemcitabine and (Nab)-Paclitaxel in Locally Advanced and Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	BYL719	Dose escalation beginning at 250 mg/day
DRUG	Gemcitabine	Dose escalation beginning at 800 mg/m\^2
DRUG	(nab)-paclitaxel	125 mg/m\^2 dose

Timeline

• Start date: 2014-10-30
• Primary completion: 2016-12-01
• Completion: 2020-01-31
• First posted: 2014-06-04
• Last updated: 2021-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study