Status:
COMPLETED
Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
Lead Sponsor:
Luye Pharma Group Ltd.
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
Brief Summary
A multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence study comparing the pharmacokinetic profile of LY01612 (Doxorubicin hydrochloride liposome injection) and CAE...
Eligibility Criteria
Inclusion
- Voluntary agreement to provide written informed consent;
- Patients aged ≥18 years and ≤75 years with locally advanced or metastatic breast cancer diagnosed by histology or cytology，and who may benefit from monotherapy of Doxorubicin liposomes;
- Life expectancy of at least 3 months; Eastern Cooperative Oncology Group (ECOG) performance status (PS)\<2;
- adequate bone marrow function \[leukocyte ≥3,000/mm3, absolute neutrophil count (ANC) ≥1,500/mm3, hemoglobin ≥90g/L, and platelet count ≥90,000/mm3；
- adequate renal function (serum creatinine ≤1.5×Institutional upper limit of normal (ULN));
- adequate coagulation function \[prothrombin time (PT), activated partial thromboplastin time (APTT) ≤1.5×ULN\];
- adequate hepatic function \[aspartate aminotransferase (AST), alanine aminotransferase (ALT) level ≤ 2.5×ULN (or ≤5×ULN for subjects with liver metastases), and total bilirubin level ≤ 1.5×ULN (or ≤ 3×ULN for subjects with liver metastases).
Exclusion
- Patients with a diagnosis of severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine, immune system, skin, musculoskeletal, neurological or psychiatric conditions that the researchers did not consider appropriate for inclusion;
- With a history of myocardial infarction, unstable angina pectoris, coronary revascularization, New York Heart Association (NYHA) grade ≥Ⅱ cardiac insufficiency, severe pericardial disease, and severe unstable ventricular arrhythmia, cerebrovascular accident or transient cerebral ischemia or pulmonary embolism within 6 months before randomization;
- Unstable brain metastases;
- Electrocardiogram (ECG) QTC \>480ms; left ventricular ejection fraction \<50% or below the lower limit of study center value;
- The total cumulative dose of doxorubicin was ﹥350mg/m2 before screening；
- Persistent or active infection requiring systemic treatment;
- Pregnancy or breast feeding;
- Other situations that investigators consider as contra-indication for this study.
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06098599
Start Date
May 17 2022
End Date
February 9 2023
Last Update
October 24 2023
Active Locations (1)
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1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China