drugset / Trial / NCT01587040

Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen

NCT01587040

Phase 1/2 Completed 61 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.

Timeline

Start
2012-07-20
Primary completion
2018-05-23
Completion
2018-05-23

Drugs

EvaluationDrugModalityDoseRoute
Subject pilaralisib Small molecule 400 mg Oral
Subject voxtalisib Small molecule 50 mg Oral

Indications