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

NCT06098599 | Completed Phase 1

• 1 other identifier: LY01612/CT-CHN-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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 (6)

• 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

• 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 Tmax

  from baseline to day 56

• Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin t1/2z

  from baseline to day 56

Study Arms (2)

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

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.

Doxorubicin hydrochloride liposome injection(CAELYX®); Doxorubicin hydrochloride liposome injection(LY01612)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: May 17, 2022
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)