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

NCT ID: NCT06098599

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2023-02-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Doxorubicin hydrochloride liposome injection(LY01612)

20mg/10mL, 50mg/m2, intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial.

Group Type: EXPERIMENTAL

Doxorubicin hydrochloride liposome injection

Intervention Type: 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®)

20mg/10mL, 50mg/m2, intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial

Group Type: ACTIVE_COMPARATOR

Doxorubicin hydrochloride liposome injection

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fourth Hospital of Hebei Medical University

Shijiazhuang, , China

Countries

China

Other Identifiers

LY01612/CT-CHN-102

Identifier Type: -

Identifier Source: org_study_id