CTRI/2017/03/008179已完成不适用
A randomized, multicenter, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of doxorubicin hydrochloride liposome injection for intravenous infusion 20 mg/10 ml (50mg/m2) of Panacea Biotec Ltd., India (investigational product) and doxorubicin hydrochloride liposome injection for intravenous infusion 20 mg/10 ml (50mg/m2) of Sun Pharmaceutical Industries ltd. (Reference drug), in patients with advanced ovarian cancer
Panacea Biotech Ltd15 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年3月27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
- 32
- 试验地点
- 15
- 主要终点
- Pharmacokinetivc Parameters namely, Cmax (Maximum Measured Plasma Concentration)
研究概览
简要总结
Doxorubicin liposomal injection is a cytotoxic drug. It would be unethical to do this study on healthy volunteers. Therefore the Bioequivalence study is proposed to be carried out in patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy with Doxorubicin liposomal injection therapy. Moreover, the guidance, issued by office of Generic drugs, for Doxorubicin hydrochloride suggests single-dose, two-way crossover in vivo study in the patients with ovarian cancer.
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
- •Female patients between 18-65 years of age.
- •(Both Inclusive)
- •Patients must be able to understand the investigational nature of this study and to give written informed consent prior to the participation in the trial.
- •Patients with histopathologically /cytologically confirmed Ovarian Cancer requiring Doxorubicin
- •Patient with Ovarian Cancer whose disease has progressed or recurred after Platinum-based Chemotherapyand who are already receiving or scheduled to start the therapy with Doxorubicin.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Cardiac function (left ventricular ejection fraction [LVEF] ≥50%.
- •Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
- •Patients with life expectancy of at least 3 months.
- •Able to comply with study requirement in opinion of Investigator.
- •Adequate hematologic status, Renal and Liver function.
- •A]Hematologic status: ANC ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Haemoglobin ≥ 9.0 g/dl B]Renal function Serum Creatinine < 1.5 times ULN.
- •C]Hepatic Function: AST and ALT < 2.5 times ULN Alkaline phosphatase < 2 times ULN phosphatase < 2 times ULN Bilirubin < ULN
- •Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must 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 12 weeks prior to study drug administration, during study and up to 30 days after the last dose of compassionate medications.
- •Cessation of birth control after this point should be discussed with a responsible physician.
- •The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol.
- •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.
排除标准
- •Pregnant or breast-feeding female.
- •Prior Doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment
- •Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.carinii or other microorganism if under treatment with myelotoxic drugs.
- •Significantly impaired hepatic function and kidney function.
- •Impaired cardiac function including any of the following conditions within past 6 months: i.
- •Unstable angina ii.
- •QTc prolongation or other significant ECG abnormalities.
- •Coronary artery bypass graft surgery.
- •Symptomatic peripheral vascular disease.
- •Myocardial infarction vi.
- •NYHA class II-IV heart failure vii.
- •Severe uncontrolled ventricular arrhythmias viii.
- •Clinically significant pericardial disease ix.
- •Electrocardiographic evidence of acute ischemic or active conduction system abnormalities x.
- •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.
- •Severe uncontrolled arrhythmias.
- •History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride liposome injection.
- •Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) 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 or HCV antibodies.
- •The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior to the first dose of investigational Product (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study).
- •Any other condition/Abnormal baseline 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.
- •Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
- •Uncontrolled hypertension (systolic blood pressure [BP] >180 or diastolic BP >100mm Hg) or uncontrolled cardiac arrhythmias (Patients with hypertension controlled by antihypertensive therapies are eligible).
- •History of cerebrovascular accident (CVA), MI within 06 months or venous thrombosis within 12 weeks.
- •(Patients with previous history of venous thrombosis on a stable dose of anticoagulation are allowed.)
- •Patients who are smokers or tobacco users in any form.
- •Past or current history of neoplasm other than the Ovarian Cancer and with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- •Patients must not have taken any potent CYP3A4 inhibitors/inducers ≤ 30 days prior to enrolment 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
Pharmacokinetivc Parameters namely, Cmax (Maximum Measured Plasma Concentration)
时间窗: Day 1 and Day 29.
AUC0-t(Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration) and
时间窗: Day 1 and Day 29.
AUC0- (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity)
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 56.)
研究者
研究点 (15)
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