Phase 1 Safety Testing of SAR405838

• Status: Completed
• Trial end date: 2018-03-05
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.