CTRI/2017/07/009118已完成不适用
A multicenter, open label, randomized, two-treatment, two-period, two-sequence, single dose, cross-over bioequivalence study of Doxorubicin Hydrochloride (Pegylated liposomal) of Dr. Reddy’s Laboratories Ltd, India, with that of Caelyx® [Doxorubicin Hydrochloride (Pegylated Liposomal)] of Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium in advanced ovarian cancer and/or metastatic breast cancer patients under fed condition
Dr Reddys Laboratories Ltd21 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年8月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 21
- 主要终点
- cancer and/or metastatic breast cancer patients under fed conditions
研究概览
简要总结
Doxorubicin Hydrochloride Liposome (Pegylated liposomal) injection is a cytotoxic drug. This Bioequivalence study is proposed to be carried out in patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy or patients of metastatic breast cancer. Primary Objective of the study is to assess the bioequivalence of the test product relative to that of reference product. Secondary Objective of the study is to monitor the safety of the patients, who are exposed to the Investigational Medicinal Product. Two consecutive treatment cycles will be used for the two treatment periods and there will be a crossover between the two periods. Patients will be randomized to receive either test or reference product as per randomization schedule. There will be a washout period of at least 28 days between two successive dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females of age between 18-65 years (both inclusive).
- •Able to understand the investigational nature of this study and give written informed consent prior to the participation in the trial.
- •Subject with advanced ovarian cancer requiring Doxorubicin and who have failed a first-line platinum-based chemotherapy regimen (Disease progression / reoccurrence after platinum based chemotherapy).
- •Or As monotherapy for subjects with metastatic breast cancer
- •Cardiac function (left ventricular ejection fraction [LVEF] ≥50%.
- •Subject should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
- •Subject with life expectancy of at least 3 months.
- •Able to comply with study requirement in opinion of Principal Investigator.
- •bin ≤ 1.5 × ULN
- •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.
- •Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, 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 30 days 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 subject in detail and subject agreed for this and it is documented in source document.
- •The investigator should ensure that the subject is using an effective method of avoiding pregnancy as per protocol.
排除标准
- •Subjects who are pregnant or breast feeding.
- •Subjects with an ECOG (Eastern Cooperative Oncology group) Performance Status Score >
- •Subject who had received prior treatment with any liposomal doxorubicin injection.
- •If total cumulative dose of Doxorubicin HCl approaches 450 mg/m
- •Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.carinii or other microorganism if under treatment with myelotoxic drugs.
- •Any other clinically significant liver or kidney disorders other than mentioned in the selection criteria.
- •Impaired cardiac function including any of the following conditions within past 6 months: 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.
- •Clinically significant pericardial disease.
- •Electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
- •Subjects 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.
- •Severe uncontrolled arrhythmias.
- •History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride Liposome (Pegylated Liposomal).
- •Use of any recreational drugs or history of drug addiction.
- •Known brain metastasis.
- •Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI criteria.
- •Other serious illness or medical condition that would prohibit the understanding and giving of informed consent.
- •A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- •A positive test result for HIV antibody and/or syphilis (VDRL).
- •Any other condition that, in the investigator’s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
- •Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
- •History of donation of blood/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.
- •Uncontrolled hypertension (systolic blood pressure [BP] >160 or diastolic BP >100mm Hg) or uncontrolled cardiac arrhythmias (Subjects with hypertension controlled by antihypertensive therapies are eligible).
- •History of cerebrovascular accident (CVA), MI within 6 months or venous thrombosis within 12 weeks.
- •(Subjects with previous history of venous thrombosis on a stable dose of anticoagulation are allowed).
- •Mental condition that would prevent subject comprehension of the nature of, and risk associated with, the study.
- •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 ≥ 5 years.
- •Subjects who have taken any potent CYP3A4 inhibitors/inducers ≤ 14 days prior to enrollment including but not limited to: ketoconazole, itraconazole, troleandomycin, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, nefazodone, fluvoxamine, diltiazem, verapamil, mibefradil, cimetidine, cyclosporine, grapefruit juice and pomelo-containing food or fluids.
结局指标
主要结局
cancer and/or metastatic breast cancer patients under fed conditions
时间窗: Day 1 and Day 29
To assess the bioequivalence of the Test Product relative to that of Reference Product in advanced ovarian
时间窗: Day 1 and Day 29
次要结局
- To monitor the safety of the patients, who are exposed to the Investigational Medicinal Product(Day 1, Day 28 and Day 57.)
研究者
研究点 (21)
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