Comparing the Pharmacokinetic Profile of LY01612 and CAEL... | NCT06098599

NCT06098599

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxorubicin hydrochloride liposome injection	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
plasma maximum concentration (Cmax) of unencapsulated doxorubicin.		from baseline to day 56
Area under Plasma concentration-time curves of unencapsulated doxorubicin.		from baseline to day 56

Secondary Outcomes

Measure	Description	Time Frame
plasma maximum concentration（Cmax） of total doxorubicin；		from baseline to day 56
Area under plasma concentration-time curves of total doxorubicin；		from baseline to day 56

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntary agreement to provide written informed consent;
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;
Life expectancy of at least 3 months; Eastern Cooperative Oncology Group (ECOG) performance status (PS)<2;
adequate bone marrow function [leukocyte ≥3,000/mm3, absolute neutrophil count (ANC) ≥1,500/mm3, hemoglobin ≥90g/L, and platelet count ≥90,000/mm3；
adequate renal function (serum creatinine ≤1.5×Institutional upper limit of normal (ULN));
adequate coagulation function [prothrombin time (PT), activated partial thromboplastin time (APTT) ≤1.5×ULN];
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:

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;
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;
Unstable brain metastases;
Electrocardiogram (ECG) QTC >480ms; left ventricular ejection fraction <50% or below the lower limit of study center value;
The total cumulative dose of doxorubicin was ﹥350mg/m2 before screening；
Persistent or active infection requiring systemic treatment;
Pregnancy or breast feeding;
Other situations that investigators consider as contra-indication for this study.](streamdown:incomplete-link)