Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer

• Status: Completed
• Trial end date: 2023-02-09
• Target enrollment: 0
• Participant gender: Female

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 CAELYX® in Chinese subjects with advanced breast cancer

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Luye Pharma Group Ltd.
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

1. Voluntary agreement to provide written informed consent;

2. 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;

3. Life expectancy of at least 3 months; Eastern Cooperative Oncology Group (ECOG) performance status (PS)<2;

4. adequate bone marrow function [leukocyte ≥3,000/mm3, absolute neutrophil count (ANC) ≥1,500/mm3, hemoglobin ≥90g/L, and platelet count ≥90,000/mm3；

5. adequate renal function (serum creatinine ≤1.5×Institutional upper limit of normal (ULN));

6. adequate coagulation function [prothrombin time (PT), activated partial thromboplastin time (APTT) ≤1.5×ULN];

7. 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 Criteria:

1. 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;

2. 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;

3. Unstable brain metastases;

4. Electrocardiogram (ECG) QTC >480ms; left ventricular ejection fraction <50% or below the lower limit of study center value;

5. The total cumulative dose of doxorubicin was ﹥350mg/m2 before screening；

6. Persistent or active infection requiring systemic treatment;

7. Pregnancy or breast feeding;

8. Other situations that investigators consider as contra-indication for this study.