The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly. Secondary objectives are: * to characterize the global safety profile * to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule * to assess preliminary evidence of anti-lymphoma activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
administered by intravenous infusion
Sanofi-Aventis Investigational Site Number 250004
Créteil, France
Sanofi-Aventis Investigational Site Number 250006
Lille, France
Sanofi-Aventis Investigational Site Number 250001
Pierre-Bénite, France
Sanofi-Aventis Investigational Site Number 250005
Rennes, France
Incidence of DLT(s) at each dose level
Time frame: during the initial 3-week period of treatment
Cumulative DLT(s)
Time frame: over the entire period of treatment
Incidence of Adverse Events and laboratory abnormalities
Time frame: study period
Tumor response (complete response, partial response) and duration of the response
Time frame: study period
Pharmacokinetics parameters
Time frame: Study period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sanofi-Aventis Investigational Site Number 250003
Rouen, France
Sanofi-Aventis Investigational Site Number 250002
Villejuif, France