drugset / Trial / NCT01571024

BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer

NCT01571024

Phase 1 Completed 17 enrolled UNC Lineberger Comprehensive Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to establish the safety and tolerability of BKM120 when combined with mFOLFOX6 and to define the maximum tolerated dose of BKM120 in this combination in advanced solid tumors including metastatic pancreatic cancer.

Timeline

Start
2012-05
Primary completion
2015-05
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Buparlisib Small molecule 40 mg Oral
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous