Advanced Breast CancerPhase 1NCT06098599
Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
A Phase 1 study testing Doxorubicin hydrochloride liposome injection in people with Advanced Breast Cancer, run by Luye Pharma Group Ltd. at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Doxorubicin hydrochloride liposome injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2022to 9 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Doxorubicin hydrochloride liposome injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxorubicin hydrochloride liposome injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Doxorubicin hydrochloride liposome injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma maximum concentration (Cmax) of encapsulated doxorubicin.
Measured: from baseline to day 56
Area under Plasma d concentration-time curves of encapsulated doxorubicin
Measured: from baseline to day 56
plasma maximum concentration (Cmax) of unencapsulated doxorubicin.
Measured: from baseline to day 56
Area under Plasma concentration-time curves of unencapsulated doxorubicin.
Measured: from baseline to day 56
Secondary outcomes (6)
plasma maximum concentration（Cmax） of total doxorubicin；
Measured: from baseline to day 56
Area under plasma concentration-time curves of total doxorubicin；
Measured: from baseline to day 56
Partial area under plasma concentration-time curves （AUC0-48h and AUC48h-t）of encapsulated doxorubicin
Measured: from baseline to day 56
Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin Tmax
Measured: from baseline to day 56
Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin t1/2z
Measured: from baseline to day 56
Adverse event
Measured: from baseline to day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start17 May 2022
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098599
- Sponsor's protocol ID
- LY01612/CT-CHN-102
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06098599
- Acronym / sponsor ID
- LY01612/CT-CHN-102
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxorubicin hydrochloride liposome injection(LY01612) | Experimental | Drug: Doxorubicin hydrochloride liposome injection20mg/10mL, 50mg/m2, intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial. |
| Doxorubicin hydrochloride liposome injection(CAELYX®) | Active comparator | Drug: Doxorubicin hydrochloride liposome injection20mg/10mL, 50mg/m2, intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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));
Key exclusion criteria (8 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxorubicin hydrochloride liposome injectionDoxorubicin 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. | Drug | Doxorubicin hydrochloride liposome injection(CAELYX®), Doxorubicin hydrochloride liposome injection(LY01612) |
Primary outcome
plasma maximum concentration (Cmax) of encapsulated doxorubicin.
Time frame: from baseline to day 56
Area under Plasma d concentration-time curves of encapsulated doxorubicin
Time frame: from baseline to day 56
plasma maximum concentration (Cmax) of unencapsulated doxorubicin.
Time frame: from baseline to day 56
Area under Plasma concentration-time curves of unencapsulated doxorubicin.
Time frame: from baseline to day 56
6 secondary outcomes
plasma maximum concentration（Cmax） of total doxorubicin；
Time frame: from baseline to day 56
Area under plasma concentration-time curves of total doxorubicin；
Time frame: from baseline to day 56
Partial area under plasma concentration-time curves （AUC0-48h and AUC48h-t）of encapsulated doxorubicin
Time frame: from baseline to day 56
Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin Tmax
Time frame: from baseline to day 56
Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin t1/2z
Time frame: from baseline to day 56
Adverse event
Time frame: from baseline to day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxorubicin hydrochloride liposome injection in people with Advanced Breast Cancer, run by Luye Pharma Group Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma maximum concentration (Cmax) of encapsulated doxorubicin. (time frame: from baseline to day 56). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.