A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection

July 2, 2020 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

A Randomized,Open-label, Single-Dose,Two-Cycle,Crossover Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers

A Randomized,Open-label, Single-Dose,Two-Cycle,Cross- Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection , 20 mg:10 mL (CSPC OuYi Pharmaceutical Technology Co, Ltd), and Caelyx®, 20 mg:10 mL (Janssen-Cilag International NV), in Advanced Breast Cancers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Fourth Hospital of Hebei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 1.Voluntary agreement to provide written informed consent. 2.Patients with locally advanced or metastatic breast cancer diagnosed by histology or cytology，and who may benefit from monotherapy of Doxorubicin liposomes.

    3.Females age 18 to 75 years, inclusive. 4.Body weight ≥45.0 kg, and BSA<1.80m2. 5.The ECOG performance status is 0 to 2. 6.The expected survival time is more than 3 months. 7.Subjects must have laboratory values within the limits described below: ANC ≥1.5 x 109/L PLT ≥100 x 109/L HB ≥90 g/L PT/INR and APTT ≤1.5 x ULN Cr ≤1.5 x ULN Serum total bilirubin ≤1.5 x ULN(OR ≤3 X ULN for subjects with liver metastases) AST (SGOT) and ALT (SGPT) ≤2.5 x ULN (OR ≤5 X ULN for subjects with liver metastases) 8.The subjects had no pregnancy plan and volunteered to use effective contraception and had no egg donation plan within 6 months after entering the study.

    9.The subject will be able to communicate well with the investigator and understand and comply with the requirements of the study.

Exclusion Criteria:

  • 1.Significant allergy, hypersensitivity or idiosyncratic reactions to doxorubicin and/or any related compounds.

    2.Treatments were terminated due to treatment failure or serious adverse reactions in subjects who had previously used doxorubicin liposomes.

    3.Patients with severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine, immune system, skin, musculoskeletal, neurological or psychiatric conditions that the researchers did not consider appropriate for inclusion.

    4.Patients who had undergone major surgery within 3 months before screening, or planned to undergo major surgery during the study period.

    5.Having a history of alcoholism, drug abuse or drug abuse. 6.The results of alcohol breath test were more than 0.0mg/100ml or drug abuse screening was positive (Methamphetamine, ketamine, MDMA,Tetrahydrocannabinol).

    7.Pregnant or breast-feeding female. 8.Positive result to any of the following: HIV-1/2, hepatitis B and C; syphilis.

    9.Study drug prior to radiation or the use of chemotherapy drugs less than 28 days, or other antineoplastic therapy (e.g., endocrine therapy, Chinese medicine treatment, the local radiotherapy of pain relief, etc.) is less than 14 days, or during the study period need to merge the other anti-tumor drug treatment.

    10.Impaired cardiac function: QTc>470ms; LVEF（left ventricular ejection fraction） below 50% or below institutional normal at screening; Congestive heart failure of grade≥ 2 from NYHA classification, myocardial infarction or uncontrolled angina pectoris occurred within 6 months before enrollment; Have had bypass surgery; 11. Blood donation or massive blood loss within 90 days before screening (> 400ml) .

    12.The total cumulative dose of doxorubicin was ≥300mg/m2 before screening, or previous administration of anthracycline caused severe cardiotoxicity.

    13.Eating a specific diet (such as grapefruit) within 48 hours prior to enrollment can affect drug absorption, distribution, metabolism, and excretion.

    14.Participating in other clinical trials and accepting clinical trial drugs within 28 days prior to enrollment.

    15.Other researchers judged unsuitable for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Doxorubicin Hydrochloride Liposome Injection
50mg/m2 ,IV on Day 1 of each cycle
Drug: Doxorubicin Hydrochloride Liposome Injection
50mg/m2,IV on Day 1 of each cycle
Active Comparator: Doxorubicin Hydrochloride Liposome Injection(Caelyx®)
50mg/m2 ,IV on Day 1 of each cycle
Drug: Doxorubicin Hydrochloride Liposome Injection
50mg/m2,IV on Day 1 of each cycle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: up to 15 days post-adminstration
The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
up to 15 days post-adminstration
AUC
Time Frame: up to 15 days post-adminstration
The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
up to 15 days post-adminstration
Tmax
Time Frame: up to 15 days post-adminstration
The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
up to 15 days post-adminstration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DRBX201901/PRO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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