BioequivalenceNCT04460820
A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
A study testing Doxorubicin Hydrochloride Liposome Injection in people with Bioequivalence, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
A Randomized,Open-label, Single-Dose,Two-Cycle,Cross- Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Bioequivalence
- 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
- 32 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2019to 23 Dec 2019
- Phase
- Interventional
- 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
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: 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.
Read the 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.
- Conditions
- Bioequivalence
- 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
50mg/m2,IV on Day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Doxorubicin Hydrochloride Liposome Injection | Experimental | 50mg/m2 ,IV on Day 1 of each cycle Receives: Drug: Doxorubicin Hydrochloride Liposome Injection |
| Doxorubicin Hydrochloride Liposome Injection(Caelyx®) | Active comparator | 50mg/m2 ,IV on Day 1 of each cycle Receives: Drug: Doxorubicin Hydrochloride Liposome Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
Measured: up to 15 days post-adminstration
AUC
The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
Measured: up to 15 days post-adminstration
Tmax
The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
Measured: up to 15 days post-adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start4 Jul 2019
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460820
- Sponsor's protocol ID
- DRBX201901/PRO
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Open-label, Single-Dose,Two-Cycle,Crossover Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers
- ClinicalTrials.gov ID
- NCT04460820
- Acronym / sponsor ID
- DRBX201901/PRO
- Conditions
- Bioequivalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 8 Jul 2020 (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 Randomized,Open-label, Single-Dose,Two-Cycle,Cross- Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxorubicin Hydrochloride Liposome Injection | Experimental | Drug: Doxorubicin Hydrochloride Liposome Injection50mg/m2 ,IV on Day 1 of each cycle |
| Doxorubicin Hydrochloride Liposome Injection(Caelyx®) | Active comparator | Drug: Doxorubicin Hydrochloride Liposome Injection50mg/m2 ,IV on Day 1 of each cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
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 Injection50mg/m2,IV on Day 1 of each cycle | Drug | Doxorubicin Hydrochloride Liposome Injection, Doxorubicin Hydrochloride Liposome Injection(Caelyx®) |
Primary outcome
Cmax
Time frame: up to 15 days post-adminstration
The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
AUC
Time frame: up to 15 days post-adminstration
The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
Tmax
Time frame: up to 15 days post-adminstration
The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
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 8 Jul 2020.
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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 study testing Doxorubicin Hydrochloride Liposome Injection in people with Bioequivalence, run by CSPC ZhongQi Pharmaceutical Technology Co., 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 3 inclusion and 12 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 8 Jul 2020. 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.
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?
Cmax (time frame: up to 15 days post-adminstration). The study lists 3 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 8 Jul 2020.