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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06098599
Other study ID # LY01612/CT-CHN-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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