A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/?Refractory Follicular Lymphoma.
Clinical Trials Register (clinicaltrials.gov)
New phase III clinical study with tazemetostat for patients with relapsed/refractory follicular lymphoma Tazemetostat - orally administered, first-in-class small molecule EZH2 inhibitor
Rekrutierung gestartet/nimmt Patienten auf
Vera Pawlik
PAREXEL International GmbH
Klinikum Westend – Haus 18
Spandauer Damm 130, 14050 Berlin
Evaluate the safety and tolerability of tazemetostat in combination with
lenalidomide + rituximab (R2) in subjects with relapsed/refractory (R/R) follicular lymphoma (FL)
and to select a recommended phase 3 dose (RP3D) of tazemetostat for further evaluation in phase 3.
Assess the pharmacokinetics of tazemetostat when administered concomitantly with R2 in subjects with R/R FL.
The RP3D of tazemetostat in combination with R2 assessed by the occurrence of
treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs).
Maximum plasma concentration (Cmax), time of Cmax (Tmax), area under the
plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration
[AUC0-t], AUC from time 0 extrapolated to infinity [AUC0-?] (single-dose only), and the apparent
terminal elimination half-life (t1/2) of tazemetostat, EPZ-6930 (desethyl metabolite), and lenalidomide
as data permit.
Nein
