Chronic Myelogenous Leukemia
Conditions
Interventions
HQP1351 1mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
HQP1351 2mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
HQP1351 4mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
HQP1351 8mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
HQP1351 12mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
HQP1351 20mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
HQP1351 30mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
HQP1351 45mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
HQP1351 60mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
HQP135140mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
HQP1351 50mg:HQP1351 orally, once every other day(QOD) for consecutive 4 weeks each cycle.
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female patients who are 18 -65 years of age; 2. CML patients in CP or AP with positive Ph chromosome or BCR-ABL fusion genes. CML Patients in CP, AP with previously treated and resistant to TKI (including T315I mutation) with Ph-positive or BCR/ABL-positive; 3. Ability to understand and willingness to sign a written informed consent form. The consent form must be signed by the patient prior to any study-specific procedures; 4. Eastern Cooperative Oncology Group (ECOG) Performance Status =3 months; 6. Adequate organ function; 7. Cardiac function index: ejection fraction (EF) > 50%; 8. QTc interval <=450ms in males, and <=470ms in females; 9. Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least 30 days following the last dose of study drug; 10. Willingness and ability to comply with study procedures and follow-up examination.
Exclusion criteria
Exclusion criteria: 1. Received chemotherapy or radiotherapy within 28 days prior to the first administration, interferon or cytarabine within 14 days prior to the first administration, or adverse events (except alopecia) caused by previous treatment and have not recovered; 2. Patients who are currently receiving treatment with a medication that has the potential to interact with research drug; 3. Have previously been treated with ponatinib (or drugs of similar composition); 4. Absorption disorder syndrome or other diseases affecting oral drug absorption; 5. Have any history of heart or vascular disease, such as hypertension (systolic blood pressure (HBP)> 140mmHg and/or diastolic blood pressure > 90mmHg), or take medications that are known to cause QT interval prolongation; 6. Mean pulmonary artery pressure >25mmHg; 7. Have a history of serious cardiovascular diseases during the previous treatment of chronic myeloid leukemia with TKI; 8. Underwent autologous or allogeneic stem cell transplant; 9. Have diseases with abnormal coagulation function; 10. Underwent major surgery (except minor surgical procedures, such as placement or bone marrow biopsy) with 14 days prior to the first dose of study drug; 11. Have a bleeding disorder within 3 months before first dose of study drug; 12. Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy; 13. Have active nervous system (CNS) disease as evidence by cytology or pathology. In the absence of clinical CNS disease, lumbar puncture is not required. History itself of CNS involvement is not exclusionary if CNS has been cleared with a documented negative lumbar puncture; 14. History of primary malignancies within the past 3 years prior to first dose of study drug (cured for more than 5 years, completely resected superficial skin cancer other than melanoma, adequately treated in-situ cancer, or controlled prostate cancer will not be considered exclusionary); 15. Active symptomatic infection (including known history of HIV or hepatitis A, B or C). Testing for these viruses is not required in the absence of history; 16. Known to be allergic to study drug ingredients or their analogues; 17. Female patients with pregnant or lactating or expecting pregnancy during the study program; 18. Suffer from any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the research drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| hematologic response (CHR);Cytogenetic response;Major molecular response (MMR);Pharmacokinetics of HQP1351 in plasma;Pharmacodynamics of HQP1351 in plasma; | — |
Countries
China
Contacts
Public ContactYifan Zhai
HealthQuest Pharma Inc.
Outcome results
None listed