临床试验/CTRI/2025/05/087517

CTRI/2025/05/087517尚未招募不适用

A Multicentre, Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover BioequivalenceStudy Between Two Formulations of Doxorubicin Pegylated Liposomal 2mg/mL Concentrate for Solution for Infusion [Qilu Pharmaceutical (Hainan)Co., Ltd. (Test Formulation) and Caelyx® Manufactured by Baxter OncologyGmbH (Reference Formulation)] in Patients with Advanced Ovarian Cancer orMetastatic Breast Cancer

Qilu Pharmaceutical (Hainan) Co., Ltd.12 个研究点分布在 1 个国家目标入组 68 人开始时间: 2025年1月6日最近更新: 2025年6月26日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Qilu Pharmaceutical (Hainan) Co., Ltd.
入组人数: 68
试验地点: 12
主要终点: To characterize the pharmacokinetic profile

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a bioequivalence Study of Doxorubicin Pegylated Liposomal 2 mg/mL Concentrate for Solution for Infusion in Patients with Advanced Ovarian Cancer or Metastatic Breast Cancer to characterize the pharmacokinetic profile and to assess the bioequivalence of test and reference product in participants with advanced ovarian cancer or metastatic breast cancer.

研究设计

研究类型: Interventional
分配方式: Random Number Table
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 75.00 Year(s)（—）
性别: Female

入选标准

•Must sign an ICF indicating that the participant understands the purpose of and procedures required for the study as described in Appendix 10.1.3 and in this protocol and is willing to participate in the study.
•Female participant with an age of 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years (completed years) of age (both inclusive), at the time of signing the informed consent.
•Participant meeting one of the following criteria: a) Participant with documented advanced ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy AND who are already receiving or scheduled to start the monotherapy with doxorubicin pegylated liposomal at a dose of 50 mg per m
•b) Participants with documented metastatic breast cancer AND who are already receiving or scheduled to start the monotherapy with doxorubicin pegylated liposomal at a dose of 50 mg per m
•Estimated life expectancy of greater than or equal to 03 months as assessed by the investigator 5) Body mass index (BMI) within the range of 18.5 to 30 kg per m2 (inclusive).
•An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 at screening visit.
•ECOG PS of 2 must be due to disease and not due to comorbid conditions.
•Participant should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
•Participants who are already receiving doxorubicin pegylated liposomal at a dose of 50 mg per m2 should not require dose reduction(s) in next planned cycle in the study due to toxicity as per the Summary of Product Characteristics (SmPC).
•Contraceptive use by participants or participants partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 8 months after the last dose of the study intervention.
•The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relation to the first dose of the study intervention.
•A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their use during the recommended period of contraception.
•A WOCBP must have a negative highly sensitive pregnancy test (serum) during screening assessments and negative highly sensitive pregnancy test (urine) on day 1 before randomisation, but no more than 3 days before the first dose of study intervention.
•If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
•In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
•Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.
•The investigator is responsible for reviewing medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy.
•The participant has adequate hematologic, liver and renal function at screening assessment a) ANC greater than or equal to 1500 per cu.mm (without granulocyte colony-stimulating factor support within 1 week prior to the date of the test) b) Platelet count greater than or equal to 75,000 per cu.mm (without any platelet transfusion per platelet concentrate within 1 week prior to the date of the test) c) Haemoglobin greater than or equal to 9.0 g per dL (Criteria must be met without erythropoietin stimulating agent dependency and without packed red blood cell (pRBC) or whole blood transfusion within 1 week prior to the date of the test) d) Estimated glomerular filtration rate (eGFR) of greater than or equal to 50 mL per min per 1.73 sq.m by CKD Epidemiology Collaboration (CKD-EPI) 2021- creatinine equation Note: Exclusionary value of the renal function can be confirmed via repeat testing if deemed necessary.
•e) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 into upper limit of normal (ULN)] (less than or equal to 4 into ULN for participants with liver metastasis) Note: Due to variability and instability, exclusionary value of the transaminases is to be confirmed via repeat testing to establish proper baseline levels.
•Willing and able to adhere to the lifestyle restrictions specified in this protocol.

排除标准

•Known allergies, hypersensitivity, or intolerance to any of the study interventions or components or excipients thereof (refer to the SmPC of Caelyx), or drug or other allergies that, in the opinion of the investigator, contraindicate participation in the study.
•Current active systemic opportunistic infection based on clinical assessment.
•Had major surgical procedure within 2 weeks before the screening, or will not have fully recovered from surgical procedure, or has surgical procedure planned during the time the participant is expected to participate in the study.
•Surgical implantation of a port catheter is not exclusionary.
•NOTE: Participants with any planned surgical procedure under local anaesthesia only may participate if they agree to seek prior approval from the investigator, and such planned procedure is not expected to prevent, limit, or confound the protocol-specified assessments as assessed by the investigator.
•Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of investigational intervention.
•Positive hepatitis C antibody test result at screening or within 3 months prior to starting the investigational intervention.
•NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be randomized only if a confirmatory negative hepatitis C RNA test is obtained.
•Has known human immunodeficiency virus (HIV) seropositive status or positive HIV test at screening.
•For participants with unknown HIV status, HIV testing will be performed at screening unless prohibited by local regulations.
•History of malignancy except disease under study within the past 3 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence.
•Current or chronic history of liver disease.
•This includes but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilsons disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator.
•Known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones).
•Participant with clinically significant current or recent (within the past 6 months before randomisation [unless otherwise specified below]) cardiac conditions as defined below: a) Acute coronary syndrome, stroke (including transient ischemic attack [TIA]) or other ischemic event or thromboembolic event (e.g., deep vein thrombosis [DVT], pulmonary embolism) b) Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification of Class II or greater c) Serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality d) Clinically significant pericardial disease e) Electrocardiographic evidence of clinically significant acute ischemic or active conduction system abnormalities at the screening f) Any other cardiac illness that could lead to a safety risk to the participant g) Participants with a known left ventricular ejection fraction (LVEF) less than 50 percentage by echocardiogram or multigated acquisition scan (MUGA) within last 28 days before randomization Note: Participants with known coronary artery disease, congestive heart failure not meeting the above criteria, must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
•h) Prior doxorubicin anthracycline exposure that would result in a total lifetime exposure of 450 mg per m2 or more after four cycles of treatment.
•Known active CNS disease, except for participants with either untreated asymptomatic brain metastases or treated brain metastases who are no longer symptomatic, with all of the following criteria are met: Only supratentorial metastases are allowed (i.e., no metastases to the midbrain, pons, medulla).
•Completed CNS-specific treatment or treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first two cycle of therapy in the study.
•No evidence of new or enlarging brain metastases or haemorrhage as ascertained by clinical examination and post-treatment follow-up brain imaging performed at least 4 weeks after CNS-directed treatment.
•Are neurologically stable without the need for steroids for at least 14 days before the first dose of the study intervention per local site assessment (anticonvulsants at a stable dose are allowed).
•NOTE: For the exclusion, LMD is a clinical diagnosis, defined as positive CSF cytology and or unequivocal radiologic or clinical evidence of leptomeningeal involvement.
•Participants with leptomeningeal symptoms in the setting of leptomeningeal enhancement would be considered to have LMD even in the absence of positive CSF cytology unless a parenchymal lesion can adequately explain the neurologic deficit.
•In contrast, an asymptomatic or minimally symptomatic participant with mild or nonspecific leptomeningeal enhancement would not be considered to have LMD AND the investigator determines that immediate CNS specific treatment is not required and is unlikely to be required during the first 2 cycle of therapy in the study.
•In that participant, CSF sampling is not required to formally exclude LMD but can be performed at the investigator’s discretion based on the level of clinical suspicion.
•Past or intended use of any disallowed therapies as noted in Section 6.9, Prior and Concomitant Therapy within 14 days prior to the first dose of the study intervention.
•Received any other investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer, or is currently enrolled in an investigational study.
•History of clinically significant drug or alcohol abuse according to medical history assessment by investigator within 1 year before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening, which is not due to current medical therapy.
•Previous randomization in the current study regardless of having received the investigational intervention or not.
•Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of the study intervention or intention to donate blood or blood products during the study.
•Documented medical history of uncontrolled, clinically significant intercurrent medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

结局指标

主要结局

To characterize the pharmacokinetic profile

时间窗: Pre-dose (0.000), 0.333, 0.667, 1.000 (end of infusion), 1.250, 1.500, 2.000, 2.500, 3.000, 5.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000, 120.000, 168.000, 216.000, 264.000, 312.000 and 360.000 hours.

and to assess the bioequivalence of

doxorubicin pegylated liposomal-Test

relative to doxorubicin pegylated

liposomal-Reference in participants with

advanced ovarian cancer or metastatic

breast cancer

次要结局

To further characterize the pharmacokinetic profile of doxorubicin pegylated liposomal-(Test relative to doxorubicin pegylated liposomal-Reference in participants with advanced ovarian cancer or metastatic breast cancer)

研究者

发起方

Qilu Pharmaceutical (Hainan) Co., Ltd.

申办方类型

Pharmaceutical industry-Global

研究点 (12)

Loading locations...

相似试验

已完成

不适用

Bioequivalence study of Doxorubicin Hydrochloride concentrate for solution for infusion 20 mg/10 ml in patients with advanced ovarian cancer and/or metastatic breast cancer.

CTRI/2020/08/027445DrReddys Laboratories70

进行中（未招募）

不适用

To compare the blood levels of liposomal Doxorubicin (Sun Pharma) with Caelyx (Pegylated Liposomal doxorubicin) of Janssen-Cilag International NV in patients with ovary and breast cancer

CTRI/2018/10/016089Sun Pharmaceutical Industries Ltd Vadodara India54

Unknown

2 期

Lipo-dox and Cyclophosphamide /5-Fluorouracil in Patients With Metastatic Breast CancerMetastatic Breast Cancer

NCT01451580TTY Biopharm47

已完成

2 期

Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDSSarcoma, KaposiHIV Infections

NCT00001059National Institute of Allergy and Infectious Diseases (NIAID)120

已完成

2 期

Liposomal Doxorubicin and Docetaxel in Metastatic Breast CancerMetastatic Breast Cancer

NCT00524810ARCAGY/ GINECO GROUP67