HMPL-523 : A Phase I, open-label, dose-escalation study of the safety and pharmacokinetics of HMPL-523 in patients with relapsed or refractory Hematologic Malignancies

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma,Diffuse Large Cell Lymphoma,Follicular Lymphoma,Lymphoma,Mantle Cell Lymphoma,Multiple Myeloma

Trial Overview Read MoreRead more

This phase I trial is evaluating a drug (HMPL-523) in patients with Chronic Lymphocytic Leukaemia, Lymphoma and Multiple Myeloma.
 

This trial is treating patients with Chronic Lymphocytic Leukaemia, Lymphoma or Multiple Myeloma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase I, open-label, dose-escalation study of the safety and pharmacokinetics of HMPL-523 in patients with relapsed or refractory Hematologic Malignancies

Commercial Sponsor

Hutchison Medipharma Limited

Summary

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.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Cabrini Education and Research Precinct
Malvern
Li Hoon Lai
lihoonlai@cabrini.com.au
(03) 9508 3421

Peninsula & South Eastern Haematology and Oncology Group
Frankston
Mr Albert Goikman
ag@paso.com.au
03 9771 8918

St Vincent's Hospital, Haematology Oncology Research
Fitzroy
Ms Lisa Demosthenous
lisa.demosthenous@svha.org.au
03 9231 3182

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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