Clinical trial NCT06098599: Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
Official title: A Multicenter, Randomized, Open-lable, Single-dose, Two-cycle, Double-cross Bioequivalence Study Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Breast Cancer
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-24
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 CAELYX® in Chinese subjects with advanced breast cancer


Eligibility 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.

Primary outcomes:
measure: plasma maximum concentration (Cmax) of encapsulated doxorubicin.
timeFrame: from baseline to day 56
measure: Area under Plasma d concentration-time curves of encapsulated doxorubicin
timeFrame: from baseline to day 56
measure: plasma maximum concentration (Cmax) of unencapsulated doxorubicin.
timeFrame: from baseline to day 56
measure: Area under Plasma concentration-time curves of unencapsulated doxorubicin.
timeFrame: from baseline to day 56
Secondary outcomes:
measure: plasma maximum concentration（Cmax） of total doxorubicin；
timeFrame: from baseline to day 56
measure: Area under plasma concentration-time curves of total doxorubicin；
timeFrame: from baseline to day 56
measure: Partial area under plasma concentration-time curves （AUC0-48h and AUC48h-t）of encapsulated doxorubicin
timeFrame: from baseline to day 56
measure: Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin Tmax
timeFrame: from baseline to day 56
measure: Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin t1/2z
timeFrame: from baseline to day 56
measure: Adverse event
timeFrame: from baseline to day 56
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
Study officials:
References: