Phase 1 Safety Testing of SAR405838

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.

Inclusion criteria:

• Histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. Patients with lymphomas may be enrolled.
• For dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status; For MTD cohort expansion, only dedifferentiated liposarcoma will be included.
• Presence of locally advanced or metastatic disease with at least one measurable lesion.

Exclusion criteria:

• Age <18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of >1.
• Life expectancy <12 weeks.
• Unstable brain or leptomeningeal disease based on history and physical examination.
• Inadequate organ functions, positive pregnancy test.
• Pregnancy or breast-feeding.
• Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) or 5 half-lives of the drug prior to study treatment, whichever is shorter, prior to study treatment.
• Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods.
• Recent (3 months) history of acute pancreatitis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.