drugset / Trial / NCT01392924

Safety and Pharmacokinetics of SAR245408 Daily Oral in Patients With Solid Tumors

NCT01392924

Phase 1 Completed 10 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: \- To confirm safety and tolerability of global recommended phase three dose (RPTD) of SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with solid tumors. Secondary Objectives: * To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408 in CDD treatment schedule in patients with solid tumors. * To gather preliminary efficacy data after repeated administration of SAR245408 in patients with solid tumors.

Timeline

Start
2011-08
Primary completion
2012-02
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject pilaralisib Small molecule Oral

Indications