TED12471: A Phase 1 dose-escalation study of the safety and pharmacokinetics of a tablet formulation of SAR245409 administered daily to patients with solid tumors or lymphoma

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TED12471: A Phase 1 dose-escalation study of the safety and pharmacokinetics of a tablet formulation of SAR245409 administered daily to patients with solid tumors or lymphoma

Primary objective
To evaluate the safety and tolerability of SAR245409 administered
as a tablet formulation on 2 treatment schedules (once daily [QD]
and twice daily [BID] dosing) in patients with solid tumors or
lymphoma
Secondary objectives
To evaluate the plasma pharmacokinetics (PK) of oral administration
of SAR245409 given as a tablet formulation on QD and BID
treatment schedules in patients with solid tumors or lymphoma
To obtain preliminary information on the effect of food on the plasma
PK of oral administration of SAR245409 as a tablet formulation in
patients with solid tumors or lymphoma

Protocol Number051201
Principal InvestigatorJanice Mehnert
PhasePhase I
ScopeNational
Applicable Disease SitesAny Site
Therapies InvolvedChemotherapy single agent systemic
Drugs InvolvedSAR245409
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.