Trial to Evaluate the Safety and Pharmacokinetics of HMPL-689 in Patients With Lymphomas
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|ClinicalTrials.gov Identifier: NCT03786926|
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : February 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: HMPL-689||Phase 1|
This is a Phase 1, open-label, multicenter study of HMPL-689 administered orally to patients with relapsed or refractory lymphoma.
This study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2).
Dose Escalation Stage (Stage 1):
This stage will end when any of the following criteria is met:
- The dose level 1 demonstrates an excessive toxicity, ie, 3 dose limiting toxicities (DLTs) are observed out of the first 3 patients at dose level 1.
- The maximum sample size is reached.
- The MTD and/or RP2D is confirmed.
Dose Expansion Stage (Stage 2):
To further characterize the safety and explore the preliminary anti-tumor activity of HMPL-689 at RP2D, patients with B cell lymphoma will be enrolled in the dose expansion stage.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-689 in Patients With Relapsed or Refractory Lymphoma|
|Actual Study Start Date :||August 26, 2019|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2023|
All patients take HMPL-689 taken daily
HMPL-689 is a PI3Kδ inhibitor
- Number of adverse events as evaluated by the NCI CTCAE v5.0 grade [ Time Frame: From first dose to within 30 days after last dose ]The safety and tolerability of HMPL-689 dose will be evaluated based on adverse events data
- maximum plasma concentration (Cmax) [ Time Frame: from cycle 1 day 1 30 min pre-dose until cycle 2 day 1 30 min pre dose (escalation) from cycle 1 day 1 30 min pre-dose to Cycle 5 day 1 pre-dose 30 min (expansion) (cycle is 28 days) ]To characterize the pharmacokinetic (PK) properties of HMPL-689 in patients with relapsed or refractory lymphoma
- Area under the concentration-time curve in a selected time interval (AUC0-t) [ Time Frame: from cycle 1 day 1 30 min pre-dose until cycle 2 day 1 30 min pre dose (escalation) from cycle 1 day 1 30 min pre-dose to Cycle 5 day 1 pre-dose 30 min (expansion) (cycle is 28 days) ]To characterize the pharmacokinetic (PK) properties of HMPL-689 in patients with relapsed or refractory lymphoma
- Objective response rate (ORR) defined as the proportion of patients who have a CR or PR [ Time Frame: from first dose to within 30 days of last dose ]To evaluate the anti-tumor activity of HMPL-689 in patients with relapsed or refractory lymphoma according to: (1) Chronic Lymphocytic Leukemia (CLL) - modified International Workshop on CLL guidelines, (2) Waldenstrom's Macroglobulinemia (WM) - consensus of international workshops on WM, (3) Lymphomas other than CLL or WM: Lugano Response Criteria for Hodgkin and Non-Hodgkin's Lymphoma
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): NCT03786926
|Contact: Vijay Jayaprakash, MDfirstname.lastname@example.org|
|Contact: Alisha Khullar, MSemail@example.com|
|Study Director:||Vijay Jayaprakash, MD||Hutchison Medipharma Limited|
|Principal Investigator:||Nilanjan Ghosh, MD||Levine Cancer Institute|
|Principal Investigator:||Jonathan B Cohen, MD||Emory Winship Cancer Institute|