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

Advanced Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098599
• Other study ID #: LY01612/CT-CHN-102
• Status: Completed
• Phase: Phase 1
• Start date: May 17, 2022
• Est. completion date: February 9, 2023

Study information

• Verified date: October 2023
• Source: Luye Pharma Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 =? 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.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Doxorubicin hydrochloride liposome injection
Doxorubicin hydrochloride liposome injection was administered intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial. Doxorubicin hydrochloride liposome injection was diluted with 250mL 5% glucose injection.

Locations

Country	Name	City	State
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang

Sponsors (1)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma maximum concentration (Cmax) of encapsulated doxorubicin.		from baseline to day 56
Primary	Area under Plasma d concentration-time curves of encapsulated doxorubicin		from baseline to day 56
Primary	plasma maximum concentration (Cmax) of unencapsulated doxorubicin.		from baseline to day 56
Primary	Area under Plasma concentration-time curves of unencapsulated doxorubicin.		from baseline to day 56
Secondary	plasma maximum concentration(Cmax) of total doxorubicin;		from baseline to day 56
Secondary	Area under plasma concentration-time curves of total doxorubicin;		from baseline to day 56
Secondary	Partial area under plasma concentration-time curves (AUC0-48h and AUC48h-t)of encapsulated doxorubicin		from baseline to day 56
Secondary	Encapsulated doxorubicin?unencapsulated doxorubicin and total doxorubicin Tmax		from baseline to day 56
Secondary	Encapsulated doxorubicin?unencapsulated doxorubicin and total doxorubicin t1/2z		from baseline to day 56
Secondary	Adverse event		from baseline to day 56