Neoplasm Malignant Clinical Trial
Official title:
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer
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.
Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death. ;
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