Overview

Phase 1 Safety Testing of SAR405838

Status:
Completed
Trial end date:
2018-03-05
Target enrollment:
Participant gender:
Summary
Primary Objectives: - To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs). - To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion. Secondary Objectives: - Pharmacokinetic (PK) profile of SAR405838. - Biomarkers in association with SAR405838. - Anti-tumor activity in response to SAR405838. - Food effect on SAR405838 PK. - Compliance with SAR405838 treatment. - Cytochrome P450 3A4/5 (CYP3A4/5) activity.
Phase:
Phase 1
Details
Lead Sponsor:
Sanofi