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Report for Clinical Trial NCT04260022

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase IB Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML)

A multi-center, open-label, randomized, phase Ib study to evaluate the PK of HQP1351 and to determine the RP2D of HQP1351 in subjects with CML CP and AP, who have experienced resistance or intolerance to at least two TKIs.

NCT04260022 Leukemia, Myeloid, Chronic Myeloid Leukemia Chronic Myeloid Leukemia
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Ascentage Pharma HQP-1351 bioavailable inhibitor

Description: HQP1351 taken by mouth every other day
Type: Drug
Group Labels: 3

HQP1351 30mg HQP1351 40mg HQP1351 50mg


Primary Outcomes

Description: To evaluate the Maximum Plasma Concentration (Cmax) of HQP1351

Measure: Maximum Plasma Concentration (Cmax) of HQP1351

Time: 27 days

Description: To evaluate the Area Under the Curve (AUC) of HQP1351

Measure: Area Under the Curve (AUC) of HQP1351

Time: 27 days

Purpose: Treatment

Allocation: Randomized

Single Group Assignment


There is one SNP

SNPs


1 T315I

Inclusion Criteria: - Patients must have CML in chronic phase (CP) or accelerated phase (AP) of any phenotype, with or without T315I mutation - Be previously treated with and developed resistance or intolerance to at least two TKIs (such as imatinib, dasatinib, nilotinib, bosutinib or ponatinib) 1. --- T315I ---

- Known allergy to any components in the study drug - Pregnant or lactating - Patients who have any conditions or illness that, according to the opinions of the investigator or the medical monitor, would comprise patient safety or interfere with the evaluation of safety and efficacy to the study drug Inclusion Criteria: - Patients must have CML in chronic phase (CP) or accelerated phase (AP) of any phenotype, with or without T315I mutation - Be previously treated with and developed resistance or intolerance to at least two TKIs (such as imatinib, dasatinib, nilotinib, bosutinib or ponatinib) 1. --- T315I ---

The randomization will be stratified to 3 groups: T315I mutated CML-CP and CML-AP, T315I un-mutated CML-CP, and T315I unmutated CML-AP to ensure that the subgroups are represented across all dose cohorts. --- T315I ---

The randomization will be stratified to 3 groups: T315I mutated CML-CP and CML-AP, T315I un-mutated CML-CP, and T315I unmutated CML-AP to ensure that the subgroups are represented across all dose cohorts. --- T315I --- --- T315I ---

The randomization will be stratified to 3 groups: T315I mutated CML-CP and CML-AP, T315I un-mutated CML-CP, and T315I unmutated CML-AP to ensure that the subgroups are represented across all dose cohorts. --- T315I --- --- T315I --- --- T315I ---



HPO Nodes


HPO: