A Study of HMPL-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms
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|ClinicalTrials.gov Identifier: NCT02857998|
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mature B-cell Neoplasms||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 27 to 42 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 200mg 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 190 patients with relapsed or refractory Hematologic Malignancies.
In this stage, approximately 190 patients with Mature B-cell Neoplasms will be enrolled with recommended phase 2 dosage 600mgQD as starting dosing. 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), Marginal zone lymphoma (MZL)and Waldenstrom's macroglobulinemia (WM)/Lymphoplasmacytic lymphoma(LPL) Subjects will receive HMPL-523 with every 28-day treatment cycle until disease progression, death, or intolerable toxicity, whichever comes first.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||217 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 Mature B-cell Neoplasms|
|Actual Study Start Date :||December 27, 2016|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
Oral administration, at dose of 200, 400, 600 and 800 mg once daily;at dose of 200,300, 400mg twice daily at Dose-escalation stage; At Dose-expansion stage, if patients dosing at 600mgQD.
Oral administration, once daily
Other Name: HMPL-523 Acetate
- Dose limited toxicities evaluated with NCI CTCAE v4.03 [ Time Frame: within 28 days 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 30 days 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): NCT02857998
|Beijing, Beijing, China|
|Contact: Jun Zhu 862188196596|
|Principal Investigator: Lin Shen, MD.PHD|
|Fudan University Shanghai Cancer Hospital||Recruiting|
|Shanghai, China, 200032|
|Contact: Junning Cao 8613651680209|