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临床试验/CTRI/2022/01/039082
CTRI/2022/01/039082进行中（未招募）不适用

A multicenter, open label, randomized, balanced, two-treatment, two-period, two-sequence, single dose, cross-over bioequivalence study of Doxorubicin hydrochloride liposome injection 2mg per mL (50 mg per m2 dose) of Sun Pharmaceutical Industries Ltd., India with that of DOXIL® (Doxorubicin hydrochloride liposome injection) 2mg per mL (50 mg per m2 dose) of Janssen Pharmaceutical, Tokyo, Japan in patients with platinum resistant recurrence or relapse mullerian carcinoma (epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer) under fed (standardized light meal) condition

Sun Pharmaceutical Industries Limited17 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年1月20日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
64
试验地点
17
主要终点
To assess the bioequivalence between Test product (Doxorubicin hydrochloride liposome injection 2mg/mL) and Reference product DOXIL® (Doxorubicin hydrochloride liposome injection 2mg/mL) in patients with platinum resistant recurrence or relapse mullerian carcinoma (epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer) under fed (standardized light meal) condition
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

A multicenter, open label, randomized, balanced, two-treatment, two-period, two-sequence, single dose, cross-over bioequivalence study of Doxorubicin hydrochloride liposome injection 2mg/mL (50 mg/m2 dose) of Sun Pharmaceutical Industries Ltd., India with that of DOXIL® (Doxorubicin hydrochloride liposome injection) 2mg/mL (50 mg/m2 dose) of Janssen Pharmaceutical, Tokyo, Japan in patients with platinum resistant recurrence or relapse mullerian carcinoma (epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer) under fed (standardized light meal) condition.

Primary objective of the study is to assess the bioequivalence between Test product (Doxorubicin hydrochloride liposome injection 2mg/mL) and Reference product DOXIL® (Doxorubicin hydrochloride liposome injection 2mg/mL) in patients with platinum resistant recurrence or relapse mullerian carcinoma (epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer) under fed (standardized light meal) condition

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • •Patient willing and able to provide voluntary informed consent prior to commencement of any study-related activities and the ability to follow the protocol requirements
  • •Female patients between 18 and 75 years of age, both inclusive and having body mass index greater or equal to 17.00 calculated as weight in kg/height in m
  • •Patients with histologically confirmed mullerian carcinoma (i.e., epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer) which is platinum-resistant, recurrence or in relapse state.
  • •Patient is able and clinically indicated to receive the recommended minimum of 2 cycles of liposomal doxorubicin HCl.
  • •Patients having Eastern Cooperative Oncology Group performance status of lesser or equal to 2 at the time of screening
  • •Life expectancy greater than 6 months based on the clinical evaluation by the investigator at the time of screening.
  • •Patients with acceptable hematology status a) Hemoglobin greater or equal to 9.0 g/dL b) Absolute neutrophil count (ANC) greater or equal to 1500 cells/μL c) Platelet count greater or equal to 75,000 cells/μL d) White blood cell counts (/ mm 3): 3,000 or more and less than 10,000
  • •Acceptable liver function: a) Alanine aminotransferase (ALT) lesser or equal to 2.5 X ULN b) Aspartate aminotransferase (AST) lesser or equal to 2.5 X ULN c) Total Bilirubin less than 1.2 mg/dL d) Alkaline phosphatase lesser or equal to 3.0 X ULN (lesser or equal to 5 × ULN for bone metastasis)
  • •Patients with creatinine clearance greater or equal to 60 mL perminute
  • •Patients with left ventricular ejection fraction greater or equal to 50 percent by an echocardiogram during screening.
  • •Patients with a negative serum pregnancy test at screening and negative urine pregnancy test on Day 0 (only for females with child bearing potential)
  • •Women of childbearing potential, (defined as women physiologically capable of becoming pregnant, unless, they must agree to use an effective method of contraception during dosing and up to six months after the last dose of study drug of the investigational product) practicing acceptable method of contraception.
  • •Acceptable methods of contraception are: a) Intrauterine device or intrauterine system b) A double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent) c) Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) d) Female sterilization (surgical bilateral oophorectomy) or tubal ligation or hysterectomy for at least 6 weeks or post-menopausal for at least one-year prior to study participation e) Total abstinence, partial abstinence is not acceptable.
  • •Patients with no history of addiction to any recreational drug or drug dependence or alcohol addiction.

排除标准

  • •Patients with known hypersensitivity or contraindication including anaphylaxis to conventional or liposomal formulations of doxorubicin, anthracycline therapy, peanut or soya or to any of their components
  • •Patients with prior doxorubicin exposure that would result in a total lifetime exposure of more than 450 mg/m2 (prior use of other anthracyclines or anthracenodiones should be included in calculations of total cumulative dosage)
  • •Patients who have received previous chemotherapy and radiation therapy within 4 weeks of dosing of Investigational Product
  • •Patients with impaired cardiac function including any of the following conditions within 6 months prior to screening: a.
  • •Unstable angina b.
  • •QTc prolongation or other significant ECG abnormalities.
  • •Coronary artery bypass graft surgery.
  • •Symptomatic peripheral vascular disease.
  • •Myocardial infarction f.
  • •NYHA class II-IV heart failure g.
  • •Severe uncontrolled ventricular arrhythmias h.
  • •Clinically significant pericardial disease i.
  • •Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  • •Patients who have received any prior mediastinal irradiation as cardiac toxicity may occur at even lower doses (400mg/m2)
  • •Patients who have received trastuzumab within 24 weeks prior to dosing of investigational product and who require as part of treatment during the study
  • •Patients taking inducers and inhibitors of CYP3A4, CYP2D6 or P-gp
  • •Pregnant or lactating women
  • •Patients with uncontrolled metabolic disorders including diabetes mellitus (HbA1c ≥ 9 %) at screening
  • •Patients with active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganism if under treatment with myelotoxic drugs
  • •Patients with known central nervous system metastasis
  • •Patients with major surgical procedure (including periodontal) within 28 days of the first dose of Investigational Product
  • •Patients with surgical or other non-healing wounds
  • •Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), syphilis.
  • •Patients with history of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer)
  • •Patients who have not recovered to Grade 0 or 1 toxicities from previous anticancer treatments or previous investigational agents.
  • •Exceptions are alopecia (any grade is acceptable), Hemoglobin greater or equal to 9.0 g/dL and fatigue (Grade 2 is acceptable) {Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0}.
  • •Patients with any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
  • •Patients who have participated in any clinical study within 90 days before the first dose of Investigational Product
  • •Patient who have donated blood and/or loss of greater or equal to 350 mL (1 unit) of blood within 90 days before the first dose of Investigational Product
  • •Patients with pre-existing motor or sensory neurotoxicity of a severity greater or equal to grade 2 by NCI criteria.
  • •Patients with a history of other clinically significant concomitant diseases including gastrointestinal, pulmonary, endocrine, immunologic, dermatologic, neurologic, psychological, musculoskeletal, cardiac, liver or renal disease, bleeding tendency.
  • •Patient with uncontrolled hypertension (systolic blood pressure [BP] higher than 180 or diastolic BP higher than 100 mm Hg) with or without antihypertensive treatment
  • •Patient with a history of cerebrovascular accident (CVA) within 6 months or venous thrombosis within 12 weeks (Patients with a previous history of venous thrombosis on a stable dose of anticoagulation are allowed)
  • •Patients with confirmed novel coronavirus infection (COVID-19).

结局指标

主要结局

To assess the bioequivalence between Test product (Doxorubicin hydrochloride liposome injection 2mg/mL) and Reference product DOXIL® (Doxorubicin hydrochloride liposome injection 2mg/mL) in patients with platinum resistant recurrence or relapse mullerian carcinoma (epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer) under fed (standardized light meal) condition

时间窗: Pre dose(0.0 hrs_ within 1 hrs prior to dosing. 0.250, 0.500, 0.750 hrs after start of infusion, Immediately after end of infusion, 0.083, 0.250,0.500, 1.000,3.000,5.000,8.000, 24.000, 48.000, 96.000 , 168.000, 240.000 ,336.000 hrs after end of infusion

次要结局

  • To monitor the adverse events and to ensure the safety of patients after investigational product administration(Not applicable)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (17)

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