A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer
- Histologically or cytologically confirmed diagnosis of a solid tumor for which no
further effective standard treatment is available. Patients with lymphomas may be
- 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
- Presence of locally advanced or metastatic disease with at least one measurable
- 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
- 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.