drugset / Trial / NCT00796731

SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma

NCT00796731 ↗

Phase 1 Completed 77 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2008-10
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject coltuximab ravtansine Unknown — Intravenous

Indications