CTRI/2018/10/016089进行中（未招募）不适用
A multicenter, open label, randomized, balanced, two-treatment, three-period, three-sequence, single dose, replicate cross-over bioequivalence study of Doxorubicin Hydrochloride Liposome Injection 2mg/mL (50 mg/m2 dose) of Sun Pharmaceutical Industries Ltd., India with that of Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal)] concentrate for solution for infusion of Janssen-Cilag International NV, Belgium in stable advanced ovarian cancer patients who have failed a first-line platinum based chemotherapy regimen or stable metastatic breast cancer patients under fed (standardized light meal) condition.
Sun Pharmaceutical Industries Ltd Vadodara India17 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年10月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
- 试验地点
- 17
- 主要终点
- •To assess the bioequivalence of the Test Product (Doxorubicin Hydrochloride Liposome Injection 2mg/mL) relative to that of Reference Product (Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal)] concentrate for solution for infusion) in stable advanced ovarian cancer patients who have failed a first-line platinum based chemotherapy regimen or stable metastatic breast cancer patients.
研究概览
简要总结
A comparative bioavailability study of Doxorubicin Hydrochloride Liposome Injection 2mg/mL (50 mg/m2 dose) of Sun Pharmaceutical Industries Ltd., India with that of Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal)] concentrate for solution for infusion of Janssen-Cilag International NV, Belgium, in stable advanced ovarian cancer patients who have failed a first-line platinum based chemotherapy regimen or stable metastatic breast cancer patients under fed (standardized light meal) condition is sponsored by Sun Pharmaceutical Industries limited. The study will be conducted at various investigator sites across India. Each subject will receive test product in one period and reference product in other 2 periods. The total duration of study for each patient will be 72 days. The primary objective of the study is to assess the comparative bioavailability between Test product and Reference product in stable advanced ovarian cancer patients who have failed a first-line platinum based chemotherapy regimen or stable metastatic breast cancer patients and to monitor the safety of Test product and Reference product.
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
- •1.Females patients with age between 18 to 75 years (both inclusive).
- •2.Ability to understand and provide written informed consent prior to participation in the study 3.Patients with stable advanced ovarian cancer requiring Doxorubicin and who have failed a first-line platinum-based chemotherapy regimen.
- •Or Patients with stable metastatic breast cancer requiring Doxorubicin as monotherapy.
- •4.Cardiac function left ventricular ejection fraction [LVEF] ≥50%.
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •6.Estimated life expectancy ≥ 3 months based on clinical evaluation by the investigator.
- •7.No persistent toxicities from prior medications at screening [Recovery to ≤ Grade 1 CTCAE v.5.0].
- •8.Able to comply with study requirement in opinion of Principal Investigator.
- •9.Adequate Hematopoietic, Renal and Liver function defined as the following: Bone marrow function: ANC greater than or equal to 1500 per mm cube; Platelet count greater than or equal to 100,000per mm cube; Haemoglobin greater than or equal to 9.0 g per dl Renal function: Serum Creatinine less than or equal to 1.5 times of upper limit of normal (ULN) Hepatic function: AST and ALT less than or equal to 2.5 times of ULN (less than or equal to 4 time of ULN for liver metastasis); Alkaline phosphatase less than or equal to 3 times of ULN (less than or equal to 5 times of ULN for bone metastasis); Total Bilirubin less than 1.2 mg per dL 10.Adequate recovery from recent surgery.
- •At least 1 week must have elapsed from the time of minor surgery; at least 4 weeks must have elapsed from the time of major surgery.
- •11.Sexually active women[unless surgically sterile (at least 6 months prior to study drug administration) or amenorrhoea for at least 12 consecutive months without an alternative medical cause ], must have negative pregnancy test at screening as well as prior to check-in and must agree to use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to six months after the last dose of study drug.
- •Cessation of birth control after this point should be discussed with a responsible physician.
- •It is investigator’s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document.
- •The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol.
排除标准
- •1.Patients who are pregnant or breast feeding.
- •2.Prior doxorubicin exposure that would result in a total lifetime exposure of more than 450 mg per meter square (Prior use of other anthracyclines or anthracenodiones should be included in calculations of total cumulative dosage).
- •3.Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.
- •carinii or other clinically significant infection at screening.
- •4.Any other clinically significant liver or kidney disorders other than mentioned in the selection criteria.
- •5.Impaired cardiac function including any of the following conditions within 6 months prior to screening: a.Unstable angina, QTc prolongation or other significant ECG abnormalities, Coronary artery bypass graft surgery, Symptomatic peripheral vascular disease, Myocardial infarction, NYHA class II-IV heart failure, Severe uncontrolled ventricular arrhythmias, Clinically significant pericardial disease, Electrocardiographic evidence of acute ischemic or active conduction system abnormalities, Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if their disease has been stable for the past six months.
- •6.History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride or the components of Caelyx®.
- •7.Presence of uncontrolled metabolic disorders including diabetes mellitus (HbA1c greater than or equal to 9 percent).
- •9.Use of any recreational drugs or history of drug addiction.
- •10.Known symptomatic or untreated or recently treated (less than or equal to 6 months of screening) central nervous system (CNS) metastases.
- •Patients with previously treated (greater than 6 months of screening) CNS metastases and are now stable and asymptomatic are allowed.
- •11.Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade 2 by NCI criteria.
- •12.Other serious illness or medical condition that would prohibit the understanding and giving of informed consent.
- •13.Patient with positive test for human immunodeficiency virus (HIV) infection, a positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- •14.The receipt of an investigational product (other than doxorubicin hydrochloride liposome injection) or participation in a drug research study within a period of 30 days or 5 half-lives (whichever is greater) prior to receiving the first dose of investigational medicinal product in the study.
- •15.Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •16.Patients with history of other clinically significant concomitant disease including gastrointestinal, pulmonary, endocrine, immunologic, dermatologic, neurologic, psychological, musculoskeletal, cardiac, liver or renal disease 17.Patients who have taken any potent inhibitors and inducers of CYP3A4, CYP2D6, or P-gp within 14 Days or 5 half-lives (whichever is greater) have not elapsed prior to receiving the first dose of investigational medicinal product in the study including but not limited to: ketoconazole, itraconazole, troleandomycin, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, nefazodone, fluvoxamine, diltiazem, verapamil, mibefradil, cimetidine, cyclosporine, and grapefruit or pomelo containing food/juice.
- •19.History of donation of blood or loss of blood (without replenishment) (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
- •20.Uncontrolled hypertension (systolic blood pressure [BP] greater than 180 or diastolic BP greater than 100 mm Hg) with or without antihypertensive treatment.
- •21.History of cerebrovascular accident (CVA) within 6 months or venous thrombosis within 12 weeks.
- •(Patients with previous history of venous thrombosis on a stable dose of anticoagulation are allowed).
- •22.Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a disease free survival greater than or equal to 5 years.
结局指标
主要结局
•To assess the bioequivalence of the Test Product (Doxorubicin Hydrochloride Liposome Injection 2mg/mL) relative to that of Reference Product (Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal)] concentrate for solution for infusion) in stable advanced ovarian cancer patients who have failed a first-line platinum based chemotherapy regimen or stable metastatic breast cancer patients.
时间窗: At the end of the study when all the patients have completed the study
次要结局
- •To monitor the adverse events.(At the end of the study when all the patients have completed the study)
研究者
研究点 (17)
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