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临床试验/CTRI/2020/08/027445
CTRI/2020/08/027445已完成不适用

A multicenter, open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, cross-over bioequivalence study of Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for solution for infusion 20 mg/10mL (2 mg/ml) of Dr. Reddy’s Laboratories Ltd, India, with that of Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate for solution for infusion (20 mg/10mL)] of Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium in advanced ovarian cancer and/or metastatic breast cancer patients under fed condition.

DrReddys Laboratories20 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年1月9日最近更新:
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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
20
主要终点
To access the bioequivalence of the test product Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for solution for infusion 20 mg/10mL (2 mg/ml) of Dr. Reddy’s Laboratories Ltd, Indiawith that of Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate for solution for infusion (20 mg/10mL)] of Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium in advanced ovarian cancer and/or metastatic breast cancer patients
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 study is Bioequivalence studyof Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for solution forinfusion 20 mg/10mL (2mg/ml) of Dr. Reddy’s Laboratories Ltd, India, with thatof Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal)concentrate for solution for infusion (20mg/10mL)] of Janssen-CilagInternational NV Turnhoutseweg 30 B-2340 Beerse Belgium in advanced ovariancancer and/or metastatic breast cancer patients under fed condition.Treatmentswill be allocated to subject by carrying out randomization using statisticaltechniques. Blood samples will be collected prior to and after start of intravenous infusion on Day 1(Period I), Day 29 (Period II).

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

  • •1.Females of age between 18-65 years (both inclusive).
  • •2.Ability to understand and provide written informed consent prior to participation in the study 3.Patients with advanced ovarian cancer requiring Doxorubicin and who have failed a first-line platinum-based chemotherapy regimen.
  • •Or As monotherapy for patients with metastatic breast cancer.
  • •4.Cardiac function (left ventricular ejection fraction [LVEF] ≥50%.
  • •5.ECOG (Eastern Cooperative Oncology group) performance status of ≤
  • •6.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
  • •7.Patients with life expectancy of at least 3 months.
  • •8.Able to comply with study requirement in opinion of Principal Investigator.
  • •9.Adequate Hematopoietic, Renal and Liver function defined as the following: Body systemParameters Bone marrow functionANC more than or equal to 1500/mm3 Platelet count more than or equal to 100,000/mm3 Haemoglobin ≥ 9.0 g/dl Renal functionSerum Creatinine ≤1.5 × upper limit of normal (ULN) Hepatic functionAST and ALT ≤3 × ULN (≤5 × ULN for liver metastasis) Alkaline phosphatase ≤2.5 × ULN (≤5 × ULN for bone metastasis and ≤4 × ULN for liver metastasis).
  • •Total Bilirubin ≤1.5 × ULN 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 (with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy 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 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/m2 3.Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.carinii or other microorganism if under treatment with myelotoxic drugs.
  • •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 past 6 months: a.Unstable angina b.QTc prolongation (QTc > 470 millisecond) or other significant ECG abnormalities.
  • •c.Coronary artery bypass graft surgery.
  • •d.Symptomatic peripheral vascular disease.
  • •e.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.
  • •j.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.
  • •k.Severe uncontrolled arrhythmias.
  • •6.History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride Liposome (Pegylated Liposomal).
  • •7.Use of any recreational drugs or history of drug addiction.
  • •8.Known brain metastasis.
  • •9.Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI criteria.
  • •10.Other serious illness or medical condition that would prohibit the understanding and giving of informed consent.
  • •11.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
  • •12.A positive test result for HIV, antibody and/or syphilis (VDRL).
  • •13.The receipt of an investigational product, or participation in a drug research study within a period of 90 days prior to the first dose of investigational Product.
  • •14.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.
  • •15.Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
  • •16.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 patient unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
  • •17.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.
  • •18.Uncontrolled hypertension (systolic blood pressure [BP] >160 or diastolic BP >100mm Hg) or uncontrolled cardiac arrhythmias (Patients with hypertension controlled by antihypertensive therapies are eligible).
  • •19.History of cerebrovascular accident (CVA), MI within 6 months or venous thrombosis within 12 weeks.
  • •(Patients with previous history of venous thrombosis on a stable dose of anticoagulation are allowed).
  • •20.Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  • •21.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.
  • •22.Patients 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, and grapefruit juice and pomelo-containing food or fluids.

结局指标

主要结局

To access the bioequivalence of the test product Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for solution for infusion 20 mg/10mL (2 mg/ml) of Dr. Reddy’s Laboratories Ltd, Indiawith that of Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate for solution for infusion (20 mg/10mL)] of Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium in advanced ovarian cancer and/or metastatic breast cancer patients

时间窗: A total of 25 blood samples will be collected during each period. The predose sample of 5mL (0.00 hr) will be collected within 5 min. prior to dosing and blood samples of 5 mL each will be drawn at 0.33, 0.66, 1.00 (i.e. at end | of infusion), 1.25, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, | 12.00, 16.00, 24.00(Day 2), 48.00(Day 3), 72.00(Day 4), 120.00(Day 6),168.00(Day 8),216.00(Day 10),288.00(Day 13) and 360.00(Day 16)hrs after start time of intravenous Infusion.

次要结局

  • •To monitor the safety of the patients, who are exposed to the Investigational Medicinal Product(Physical examination,vital signs,ECG,laboratory evaluations and adverse event monitoring)

研究者

发起方
DrReddys Laboratories
申办方类型
Pharmaceutical industry-Indian

研究点 (20)

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