Use the hyperlinks, where available to access additional clinical trial information.
A Phase I, open-label, dose-escalation study of the safety and pharmacokinetics of HMPL-523 in patients with relapsed or refractory Hematologic Malignancies
Hutchison Medipharma Limited
There are two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2).
Dose-escalation stage (stage 1) The conventional 3+3 design (3 patients per dose cohort, with the potential to add additional 3 patients to the same cohort to further evaluate toxicity) will be applied for dose escalation and maximum tolerated dosage determination. Approximately 18 to 27 dose limited toxicities evaluable patients will be enrolled. The actual number of patients depends on the dose limited toxicities situation as well as the maximum tolerated dosage reached at this stage.
Dosing will begin at 100mg once daily. A cycle of study treatment will be defined as 28 days of continuous dosing.
Dose-expansion stage(stage 2) This phase is to further evaluate the safety, the pharmacokinetics and anti-tumor activity of HMPL-523 at recommended phase 2 dosage in approximately 20patients with relapsed or refractory B-cell Non-Hodgkin's Lymphomas or Chronic Lymphocytic Leukemia.
In this stage, approximately 20 patients with B-cell Non-Hodgkin's Lymphomas or Chronic Lymphocytic Leukemia will be enrolled with recommended phase 2 dosage as starting dose. The tumor types of the expansion stage are restricted to Chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL), Mantle cell lymphoma (MCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) and Waldenstrom's macroglobulinemia (WM) Subjects will receive HMPL-523 with every 28-day treatment cycle until disease progression, death, or intolerable toxicity, whichever comes first.