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

Phase 1

Completed

• Conditions: Advanced Breast Cancer
• Interventions: Drug: Doxorubicin hydrochloride liposome injection

• Registration Number: NCT06098599
• Lead Sponsor: Luye Pharma Group Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-17
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Status Verified: 2023-10
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Doxorubicin hydrochloride liposome injection(CAELYX®)	Doxorubicin hydrochloride liposome injection	20mg/10mL, 50mg/m2, intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial
Doxorubicin hydrochloride liposome injection(LY01612)	Doxorubicin hydrochloride liposome injection	20mg/10mL, 50mg/m2, intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial.

Primary Outcome Measures

Name	Time	Method
plasma maximum concentration (Cmax) of encapsulated doxorubicin.	from baseline to day 56
Area under Plasma d concentration-time curves of encapsulated doxorubicin	from baseline to day 56
Area under Plasma concentration-time curves of unencapsulated doxorubicin.	from baseline to day 56
plasma maximum concentration (Cmax) of unencapsulated doxorubicin.	from baseline to day 56

Secondary Outcome Measures

Name	Time	Method
Partial area under plasma concentration-time curves （AUC0-48h and AUC48h-t）of encapsulated doxorubicin	from baseline to day 56
Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin t1/2z	from baseline to day 56
Area under plasma concentration-time curves of total doxorubicin；	from baseline to day 56
Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin Tmax	from baseline to day 56
plasma maximum concentration（Cmax） of total doxorubicin；	from baseline to day 56
Adverse event	from baseline to day 56

Trial Locations

Locations (1)

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, China