Breast CancerPhase 1NCT05273944

Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection (Lipodox®) in Chinese Patients

A Phase 1 study testing Doxorubicin Hydrochloride Liposome Injection in people with Breast Cancer and Ovarian Cancer, run by Shenzhen Kangzhe Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Bioequivalence study is proposed to be carried out on patients of breast cancer/ ovarian cancer, who are administrated for Doxorubicin Hydrochloride Liposomal Injection Lipodox® or Caelyx® in a dose of 50 mg/m2. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Breast Cancer, Ovarian 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: 80 participants
Where: 1 siteChina
Study dates: 28 Jul 2021to 30 Apr 2022
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

The subjects fully understand the purpose, nature, methods and possible adverse reactions of the study, voluntarily participate in the study, and sign informed consent before the study procedure begins;
Adult female subjects between 18 to 75 years of age (both inclusive) at the time of screening visit. Body weight is greater than or equal to 40.0 kg. Body surface area (BSA) is less than 1.8 m2;
Subjects with histologically or cytological proven: 1) Advanced ovarian cancer patients who had previously failed first-line platinum-containing chemotherapy; Or 2) metastatic breast cancer;
ECOG performance status ≤ 2;
Life expectancy of at least 3 months;
Adequate renal, hepatic function:

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Neutrophils ≥1.5×109/L;
Leukocyte≥3×109/L;
Platelet count ≥ 80×109/L;
Hemoglobin (Hb) ≥ 90g/L;
Serum creatinine ≤ 1.5 x ULN;
AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN (for liver metastasis≤ 5 x ULN);
Prothrombin time (PT)/activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
Total bilirubin≤ 1.5 x ULN (for liver metastasis≤ 3 x ULN);
Alkaline phosphatase ≤ 2.5 x ULN;
Subjects (including spouse) who have no childbearing plans in the next 6 months and voluntarily take effective contraceptive measures.

Who cannot join

History of allergy to doxorubicin or any components of doxorubicin; or those with allergic constitution: such as those who are allergic to two or more drugs and food;
Previous treatment with Doxorubicin Liposome, and discontinue treatment due to treatment failure or severe adverse reactions;
Patients who have previously received more than 400 mg/m2 doxorubicin (Conversion of other anthracyclines and anthraquinone: 1 mg doxorubicin is equivalent to 2 mg epirubicin, or 2 mg pirarubicin, or 2 mg daunorubicin, or 0.5 mg dimethoxy-daunorubicin , or 0.45 mg mitoxantrone), or severe cardiotoxicity from prior exposure to anthracyclines;
Positive history of known spinal cord compression or brain metastases (unless asymptomatic, stable for more than 4 weeks, steroid treatment was discontinued at least 4 weeks prior to first administration of Lipodox®/ Caelyx®, and no radiographic evidence of significant edema around the tumor lesion). Untreated patients with disease progression due to brain metastases in the last treatment prior to screening;
Subjects with other known active malignancies that require treatment within 5 years;
Patients with abnormal cardiac function: ECG examination, QTc>480ms; left ventricular ejection fraction(LVEF)<55%；congestive heart failure, myocardial infraction, or uncontrolled angina pectoris of New York Heart Society≥2 within 6 months prior to enrollment; have undergone heart bypass surgery; Tropoin≥1.5 x ULN；N-terminal brain natriuretic peptide ≥1.5 x ULN; The investigator evaluated the overall cardiac function of the subjects by integrating all examination items.

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Patients with poor control of hypertension (systolic≥160 mmHg, diastolic>80 mmHg;
Diabetes blood glucose control is not up to standard, fasting blood glucose >11.1 mol/L, or accompanied by diabetic complications (diabetic nephropathy, peripheral neuropathy);
Radiation therapy or chemotherapy drugs (paclitaxel, cyclosporine, dexrazoxane, cytarabine, streptozotocin, etc.) within 4 weeks before study administration prior to administration, or other anti-tumor therapies such as endocrine therapy, traditional Chinese medicine, and local radiation therapy to relieve pain;
Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug, or plan to undergo major surgery during the study period and those who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion;
Use of drugs that induce or inhibit liver drug enzymes in the previous 4 weeks prior to administration and during the study (such as: Barbiturates, carbamazepine, phenytoin, griseofulvin);
The special diet within 7 days before the study administration may affect drug absorption, distribution, metabolism and excretion during the study, including but no limited to: taking special diets that may image drug metabolism including dragon fruit, mango, grapefruit, lime, carambola, chocolate, or by the preparation of food or drink, or a diet containing caffeine, xanthine, etc;
Patients who consumed excessive amounts of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, one cup=250mL) daily for 3 months prior to administration;
Patients who smoked more than 5 cigarettes per day during the 3 months prior to administration, or who did not agree to refrain from using any tobacco products during the study;
Drinking more than 14 units of alcohol per week in the 3 months prior to administration (1 unit of alcohol≈360mL beer or 45mL 40% alcoholic spirits or 150mL wine);
Pregnant women, breast-feeding women or women of childbearing age who are screened for positive pregnancy tests, or who do not agree to use effective contraceptive measures during the trial or whose spouse plans to give birth within 6 months;
Patients with positive hepatitis B virus surface antigen (HBsAg) test results and HBV-DNA ≥104 copy number or ≥2000IU/ML, or those with other active infectious diseases (such as hepatitis C, syphilis, or human immunodeficiency virus HIV infection);
Subjects who received vaccine within 1 month prior to administration;
Previous history of drug abuse;
Patients who cannot withstand venipuncture, have a history of needle sickness and blood sickness, or have difficulty in venous blood collection;
Patients who had donated blood or lost blood of ≥400mL within 3 months prior to administration, or intended to donate blood (including blood components) during 3 months after the study;
The investigator determined that subjects were unsuitable for this study.

Trial locations and contacts

1 site in 1 country.

Herui Yao contact

81332107 ext. 020

yaoherui@163.com

China1 site, 1 recruiting

Sun Yat-Sun Memorial Hospital, Sun Yat-Sun University
Guangzhou, Guangdong, 510120
Herui Yao, 81332107 ext. 020, yaoherui@163.com
Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Single-dose, Two-preparation, Two-sequence, Two-cycle Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection in Patients With Breast Cancer/Ovarian Cancer

Read the detailed description

This study is a randomized, open-label, single-dose, two-preparation, two-sequence, two-cycle crossover bioequivalence study. This study will be conducted in female subjects aged 18 to 75 years diagnosed with breast cancer/ ovarian cancer. Each subject will be randomized to two treatment sequences (RT or TR) with equal numbers of patients according to a randomization scheme prepared to start of the trial. The cleaning period was 28-42 days. Serial blood samples for determination of free and liposomal encapsulated doxorubicin plasma concentration for PK analysis will be obtained in each cycle. Blood samples to be obtained at 0 h (within 60 min) before infusion, 15 min, 30 min, 45 min, 60 min, 75 min, 90min after the beginning of infusion, 15 min, 30 min, 1.0 h, 3.0 h, 5.0 h, 8.0 h, 16.0 h, 24.0 h, 36.0 h, 48.0 h, 96.0 h, 168.0 h, 240.0 h, 336.0 h after infusion completed.

Conditions: Breast Cancer, Ovarian Cancer
Being tested: Doxorubicin Hydrochloride Liposome Injection
Medical subject headings: Breast Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Doxorubicin Hydrochloride Liposome InjectionDrug
Also called Caelyx®/Lipodox®
50mg/m2, intravenous drip on Day 1 of each cycle. On Day 1 of Cycle 1 patients will receive either reference or test product. On Day 1 of Cycle 2, patients will crossover to the alternate reference or test formulation. To measure pharmacokinetic paratemers of Caelyx® versus Lipodox®.

Study groups in NCT05273944
Study group	Role	What they receive
Reference product-R	Active comparator	Caelyx® (Janssen-Cilag International NV); 20 mg/10 mL (50 mg/m2 dose). As this is a crossover study, subjects receiving the Reference Product (Caelyx®) in Cycle 1, will receive the Test Product (Lipodox®) in Cycle 2. Cycle is defined as 28-42 days (RT). Receives: Drug: Doxorubicin Hydrochloride Liposome Injection
Test Product-T	Experimental	Lipodox® (Sun Pharmaceutical Industries Ltd.); 20 mg/10 mL (50 mg/m2 dose). As this is a crossover study, subjects receiving the Test Product (Lipodox®) in Cycle 1, will receive the Reference Product (Caelyx®) in Cycle 2. Cycle is defined as 28-42 days (TR). Receives: Drug: Doxorubicin Hydrochloride Liposome Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Maximum observed plasma concentration
Measured: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
AUC[0-t]
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration
Measured: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
AUC[0-∞]
Area under the plasma concentration-time curve from 0 extrapolated to infinite time
Measured: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed

Secondary outcomes (8)

AUC[0-48hours]
Area under the plasma concentration-time curve from time of intake until 48hours post-dose
Measured: Pre-dose (within 60 minutes) , 15, 30, 45, 60, 75, 90minutes after the beginning of infusion, 15 minutes, 30 minutes, 1, 3, 5, 8, 16, 24, 36, 48hours after infusion completed
AUC[48hours-t]
Area under the plasma concentration-time curve from time of 48hours post-dose until the 336hours posy-dose
Measured: 48hours post-dose to the 336hours post-dose
Tmax
Time to reach the maximum observed plasma concentration
Measured: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
λz
Elimination rate constant
Measured: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
t1/2z
Elimination half-life
Measured: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
AUC_%Extrap
Percentage of remaining area，Calculate as [(AUC[0-∞]- AUC[0-t]）/ AUC[0-∞]]×100%
Measured: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15 minutes, 30 minutes, 1,3,5,8,16,24,36,48,96,168,240,336 hours after infusion completed
CL/F
Apparent clearance
Measured: Pre-dose (within 60 minutes), 15,30, 45,60,75,90 minutes after the beginning of infusion, 15 minutes, 30 minutes, 1,3,5,8,16,24,36,48,96,168,240,336 hours after infusion completed
Vd/F
Apparent volume of distribution
Measured: Pre-dose (within 60 minutes), 15,30, 45,60,75,90 minutes after the beginning of infusion, 15 minutes, 30 minutes, 1,3,5,8,16,24,36,48,96,168,240,336 hours after infusion completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202130 Apr 2022

First posted10 Mar 2022
Study start28 Jul 2021
Primary completion31 Mar 2022 (estimated)
Study completion30 Apr 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
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: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05273944
Sponsor's protocol ID: DHLI-BC/OC-BE-001
Status last verified: Feb 2022
First submitted: 10 Feb 2022
Last updated: 10 Mar 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Herui Yao

81332107 ext. 020

yaoherui@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Single-dose, Two-preparation, Two-sequence, Two-cycle Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection in Patients With Breast Cancer/Ovarian Cancer
ClinicalTrials.gov ID: NCT05273944
Acronym / sponsor ID: DHLI-BC/OC-BE-001
Conditions: Breast Cancer, Ovarian Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Hunan Cancer Hospital, The Second Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Jinan University, Zhejiang Provincial People's Hospital, Yuncheng Central Hospital, Shantou Central Hospital, Yuebei People's Hospital, Cancer Hospital of Guizhou Province, Guangzhou Panyu Central Hospital, Dongguan People's Hospital
Study start: 28 Jul 2021 (actual)
Primary completion: 31 Mar 2022 (estimated)
Study completion: 30 Apr 2022 (estimated)
First posted: 10 Mar 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Reference product-R	Active comparator	Drug: Doxorubicin Hydrochloride Liposome InjectionCaelyx® (Janssen-Cilag International NV); 20 mg/10 mL (50 mg/m2 dose). As this is a crossover study, subjects receiving the Reference Product (Caelyx®) in Cycle 1, will receive the Test Product (Lipodox®) in Cycle 2. Cycle is defined as 28-42 days (RT).
Test Product-T	Experimental	Drug: Doxorubicin Hydrochloride Liposome InjectionLipodox® (Sun Pharmaceutical Industries Ltd.); 20 mg/10 mL (50 mg/m2 dose). As this is a crossover study, subjects receiving the Test Product (Lipodox®) in Cycle 1, will receive the Reference Product (Caelyx®) in Cycle 2. Cycle is defined as 28-42 days (TR).

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

The subjects fully understand the purpose, nature, methods and possible adverse reactions of the study, voluntarily participate in the study, and sign informed consent before the study procedure begins;
Adult female subjects between 18 to 75 years of age (both inclusive) at the time of screening visit. Body weight is greater than or equal to 40.0 kg. Body surface area (BSA) is less than 1.8 m2;
Subjects with histologically or cytological proven: 1) Advanced ovarian cancer patients who had previously failed first-line platinum-containing chemotherapy; Or 2) metastatic breast cancer;
ECOG performance status ≤ 2;
Life expectancy of at least 3 months;

Key exclusion criteria (22 listed)

History of allergy to doxorubicin or any components of doxorubicin; or those with allergic constitution: such as those who are allergic to two or more drugs and food;
Previous treatment with Doxorubicin Liposome, and discontinue treatment due to treatment failure or severe adverse reactions;
Patients who have previously received more than 400 mg/m2 doxorubicin (Conversion of other anthracyclines and anthraquinone: 1 mg doxorubicin is equivalent to 2 mg epirubicin, or 2 mg pirarubicin, or 2 mg daunorubicin, or 0.5 mg dimethoxy-daunorubicin , or 0.45 mg mitoxantrone), or severe cardiotoxicity from prior exposure to anthracyclines;
Positive history of known spinal cord compression or brain metastases (unless asymptomatic, stable for more than 4 weeks, steroid treatment was discontinued at least 4 weeks prior to first administration of Lipodox®/ Caelyx®, and no radiographic evidence of significant edema around the tumor lesion). Untreated patients with disease progression due to brain metastases in the last treatment prior to screening;
Subjects with other known active malignancies that require treatment within 5 years;

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 InjectionAlso: Caelyx®/Lipodox®50mg/m2, intravenous drip on Day 1 of each cycle. On Day 1 of Cycle 1 patients will receive either reference or test product. On Day 1 of Cycle 2, patients will crossover to the alternate reference or test formulation. To measure pharmacokinetic paratemers of Caelyx® versus Lipodox®.	Drug	Reference product-R, Test Product-T

Primary outcome

Cmax
Time frame: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
Maximum observed plasma concentration
AUC[0-t]
Time frame: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration
AUC[0-∞]
Time frame: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
Area under the plasma concentration-time curve from 0 extrapolated to infinite time

8 secondary outcomes

AUC[0-48hours]
Time frame: Pre-dose (within 60 minutes) , 15, 30, 45, 60, 75, 90minutes after the beginning of infusion, 15 minutes, 30 minutes, 1, 3, 5, 8, 16, 24, 36, 48hours after infusion completed
AUC[48hours-t]
Time frame: 48hours post-dose to the 336hours post-dose
Tmax
Time frame: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
λz
Time frame: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
t1/2z
Time frame: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed
AUC_%Extrap
Time frame: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15 minutes, 30 minutes, 1,3,5,8,16,24,36,48,96,168,240,336 hours after infusion completed
CL/F
Time frame: Pre-dose (within 60 minutes), 15,30, 45,60,75,90 minutes after the beginning of infusion, 15 minutes, 30 minutes, 1,3,5,8,16,24,36,48,96,168,240,336 hours after infusion completed
Vd/F
Time frame: Pre-dose (within 60 minutes), 15,30, 45,60,75,90 minutes after the beginning of infusion, 15 minutes, 30 minutes, 1,3,5,8,16,24,36,48,96,168,240,336 hours after infusion completed

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.

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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.

Herui Yao contact

81332107 ext. 020

yaoherui@163.com

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 Breast Cancer and Ovarian Cancer, run by Shenzhen Kangzhe Pharmaceutical 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 16 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Herui Yao (81332107 ext. 020, yaoherui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Pre-dose (within 60 minutes), 15,30, 45,60,75,90minutes after the beginning of infusion, 15minutes, 30minutes, 1,3,5,8,16,24,36,48,96,168,240,336hours after infusion completed). 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?

On the ClinicalTrials.gov record for NCT05273944.

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 10 Mar 2022.