A Multicenter, Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Cross-Over, Bioequivalence Study of Doxorubicin Hydrochloride (Pegylated Liposomal) in comparison with CaelyxÂ® [Doxorubicin Hydrochloride (Pegylated Liposomal)] in Patients with Ovarian Cancer.

Intas Pharmaceuticals Ltd19 个研究点分布在 1 个国家目标入组 66 人开始时间: 2018年1月2日最近更新: 2019年4月24日

试验速览

阶段: 不适用
状态: 已完成
发起方: Intas Pharmaceuticals Ltd
入组人数: 66
试验地点: 19
主要终点: Assessment of bioequivalence of the test product [Doxorubicin Hydrochloride (Pegylated Liposomal) 2

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 is a multicenter, open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, cross-over, bioequivalence study. Doxorubicin Hydrochloride (Pegylated 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 who are already receiving or scheduled to start therapy with Doxorubicin Hydrochloride (Pegylated liposomal) injection therapy. The risk of ovarian cancer goes up with age. The majority of cases are diagnosed in women over 45 years of age. The median age that ovarian cancer is diagnosed is 63 years. Therefore, we are enrolling patients of advanced ovarian cancer with age in between 18-75 years. In Period 1, patients will be dosed with Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate for solution for infusion (either test or reference product as per the randomization schedule) on the first day of the chemotherapy cycle under standard diet condition. Patients will be crossed over to another arm in Period 2 after a wash out period of at least 28 days. Total 66 patients will be enrolled in this study. The patients will have to stay for at least three consecutive nights in the facility. There will be a washout period of at least 28 days (window period of +14 days for adverse event management will be allowed between two periods of the study) between two successive dosing. In case of any adverse event, necessary action will be taken till the event subsides. The study will commence only after a written approval is obtained from the IEC and applicable regulatory authorities.

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 75.00 Year(s)（—）
性别: Female

入选标准

•Female patients between 18-75 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.
•Patient with confirmed Ovarian Cancer whose disease has progressed or recurred after platinum based Chemotherapy who are already receiving or scheduled to start the therapy with Doxorubicin HCl (Pegylated Liposomal) 2 mg/ml (20 mg/10 mL) concentrate for solution for infusion.
•Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
•Cardiac function (left ventricular ejection fraction [LVEF] greater than or equal to 50 percentage.
•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.
•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
•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/meter square 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
•History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate for solution for infusion.
•Known brain metastasis.
•Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to 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.
•Patient with HIV and/or syphilis.
•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 investigatorâ€™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 or uncontrolled cardiac arrhythmias
•History of cerebrovascular accident (CVA), MI within 06 months or venous thrombosis within 12 weeks.
•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 less than or equal to 30 days prior to enrollment.