A Study of HMPL-523 in Relapsed or Refractory Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT02503033|
Recruitment Status : Active, not recruiting
First Posted : July 20, 2015
Last Update Posted : September 11, 2020
The purpose of this study is to evaluate the safety and tolerability of HMPL-523 administered to patients with relapsed or refractory Hematologic Malignancies
To determine the maximum tolerated dosage/recommended phase 2 dosage and characterize the dose limited toxicities associated with HMPL-523 when administered to patients with relapsed or refractory Hematologic Malignancies
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Drug: HMPL-523||Phase 1|
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 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 include QD (quaque die) and bis in die (BID) cohorts. A cycle of study treatment will be defined as 28 days of continuous dosing.
Dose-expansion stage (stage 2). In this stage, approximately 40 patients with B-cell Non-Hodgkin's Lymphomas or Chronic Lymphocytic Leukemia will be enrolled with 600mg once daily 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) (Grade 1-3a), Marginal zone lymphoma (MZL) and Waldenstrom's macroglobulinemia / Lymphoplasmacytic lymphoma (WM/LPL). Subjects will receive HMPL-523 600mg once daily with every 28-day treatment cycle until disease progression, death, or intolerable toxicity, whichever comes first.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2021|
Oral administration, at a dose of 100, 200, 400, 600, 800 and 1000mg once daily or 300mg and 400mg twice daily at Dose-escalation stage.
At the Dose-expansion stage, HMPL-523 600mg will be dosed once daily.
Oral administration, once daily
- dose limited toxicities evaluated with NCI CTCAE v4.03 [ Time Frame: within 28days after the first dose ]Incidence of dose limited toxicities and associated dose of HMPL-523
- maximum plasma concentration calculated with Blood samples [ Time Frame: within 29 days after the first dose ]Blood samples will be taken to measure the levels of study drug
- time to reach maximum concentration calculated with Blood samples [ Time Frame: within 29 days after the first dose ]Blood samples will be taken to measure the levels of study drug
- Objective response rate [ Time Frame: within 30 days after the last dose ]the proportion of subjects who have a Complete Response or Partial Response
- adverse events evaluated by NCI CTCAE v4.03 [ Time Frame: from the first dose to within 30days after the last dose ]Incidence of adverse events and associated dose of HMPL-523
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503033
|Australia, Australian Capital Territory|
|Canberra, Australian Capital Territory, Australia|
|Australia, New South Wales|
|Border Medical Oncology Research Unit|
|Albury, New South Wales, Australia, 2640|
|Liverpool, New South Wales, Australia|
|Townsville, Queensland, Australia, 4814|
|Australia, South Australia|
|Royal Adelaide Hospital|
|Adelaide, South Australia, Australia|
|Ballarat Regional Integrated Cancer Centre|
|Ballarat, Victoria, Australia, 3350|
|St Vincent's Hospital|
|Fitzroy, Victoria, Australia|
|Peninsula & South Eastern Haematology and Oncology Group|
|Frankston, Victoria, Australia|
|Geelong, Victoria, Australia, 3220|
|Heidelberg, Victoria, Australia|
|Melbourne, Victoria, Australia, 3144|
|Australia, Western Australia|
|Royal Perth Hospital|
|Perth, Western Australia, Australia, 6000|
|Study Director:||Chen Yu, MD||Hutchison Medi Pharma|