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
