drugset / Trial / NCT00549185

Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma

NCT00549185 ↗

Phase 1 Completed 39 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective is to determine the maximum tolerated dose of SAR3419 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-lymphoma activity, the global safety and the PK profile.

Timeline

Start
2007-10
Primary completion
2012-01
Completion
2012-01

Outcome

Met primary endpoint

release “establish the MTD of SAR3419 when administered once every three weeks. This was determined to be 160 mg/m 2 .” abbvie.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject coltuximab ravtansine Unknown — Intravenous

Indications