A Multicentric, Open-label, Randomized, Two Treatment, Two Sequence, Cross Over, Clinical Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection (IV) 2 mg/ml (50mg/m2) of Auromedics Pharma LLC, USA (Test) With Doxorubicin Hydrochloride Liposome Injection (IV) 2 mg/ml (50mg/m2) of Sun Pharmaceutical Industries, Inc, USA (Reference) in Ovarian Cancer Patients whose disease has progressed or recurred after platinum-based chemotherapy under fasting conditions - CR150-16

APL Research Center0 个研究点目标入组 71 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 71

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Ba/be

入排标准

入选标准

•1.Patients must be above 18 and below 75 years of age
•2.Life expectancy of greater than or equal to 12 weeks.
•3.Histologically or cytologically confirmed diagnosis of epithelial ovarian carcinoma (FIGO Stage II to IV) and who are already receiving or scheduled to start therapy with the Liposomal Doxorubicin.
•4.One or 2 previous chemotherapy regimens for advanced ovarian cancer. At least one of these regimens must have contained a platinum agent.
•5.Patients who are either platinum-resistant (relapse less than 6 months after completing a platinum-containing regimen) or platinum sensitive (relapse above or equal to 6 months after platinum-containing regimen) are eligible.
•6.Cytological or imaging confirmation of ovarian cancer recurrence after platinum therapy.
•7.Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
•8.Normal left ventricular ejection fraction (LVEF greater than 50%) according to institutional standards. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (with the exception of port-a-cath placement); at least 4 weeks must have elapsed from the time of a major surgery.
•9.Laboratory values as follows:
•Absolute neutrophil count (ANC) greter than or equal to 1500/ÂµL.
•Hemoglobin (Hb)greater than or equal to 9g/dL. Patients may not have received RBC transfusions within 7 days of screening assessment.
•Platelets greated than or equal to 100,000/ ÂµL.
•AST or ALT must be less than 2.5 x ULN (concomitant elevations in bilirubin and AST/ALT greater than 1.0 x ULN are not permitted).
•Total bilirubin less than 1.2 x the institutional ULN (if Gilberts syndrome, direct bilirubin less than or equal to 1.2 x ULN).
•International normalized ratio (INR) less than or equal to 1.2 and activated partial thromboplastin time (aPTT) less than or equal to 1.2 x the ULN (except for patients receiving anti-coagulation therapy).
•Creatinine greater than or equal 1.5 x ULN.
•10.Patients and/ or LAR must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
•11.Women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation and for 180 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test within 20 days prior to initiation of treatment.
•12.Females must use acceptable and effective methods of contraception such as the following:
•Tubal sterilization (tubal ligation performed more than one month before Study Day 1; transcervical tubal occlusion procedure performed more than six months before Study Day 1)
•Intrauterine Device (IUD)
•Progestin Implant (i.e. Implanon or its equivalent)
•Progestin injection or progestin oral contraceptive pill + one barrier method (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom)
•Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom)
•Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner)
•13.Post-menopausal women must be amenorrheic for at least 12 months be considered of

排除标准

•1.Patients who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin hydrochloride or the components.
•2.Prior doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment.
•3.Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P. carinii or other microorganism if under treatment with myelotoxic drugs.
•4.Patients with brain metastases.
•5.Patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.
•6.Patients with significantly impaired hepatic OR renal function
•7.Patients with hemoptysis within 6 weeks of first dose of study drug.
•8.Patients who are pregnant or breast feeding.
•9.Impaired cardiac function including any of the following conditions within the past 6 months:
•NYHA Class II, III or IV heart failure.
•QTc prolongation or other significant ECG abnormalities.
•Myocardial infarction or unstable angina.
•Coronary artery bypass graft surgery.
•Symptomatic peripheral vascular disease.
•History of sustained ventricular tachycardia.
•10.Patients who have taken any potent CYP3A4 inhibitors within or equal to 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.
•11.Uncontrolled hypertension [systolic blood pressure (BP)greater than 180 or diastolic BP greater than 100mm Hg] or uncontrolled cardiac arrhythmias (Patients with hypertension controlled by antihypertensive therapies are eligible.)
•12.History of cerebrovascular accident (CVA), or venous thrombosis within 12 weeks (Patients with previous history of venous thrombosis on a stable dose of anticoagulation are allowed).
•13.Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
•14.Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or significant small bowel resection).
•15.Mental condition that would prevent patient comprehension of the nature of, and risk associated with the study.
•16.Use of any non-approved or investigational agent within or equal to 30 days prior to Randomization. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
•17.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.
•18. A positive hepatitis screen including hepatitis B surface antigen, HCV and HIV antibodies.
•19.Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
•20.Patients experience Hand foot syndrome, hematologic toxicities and Stomatitis or any othe

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发起方

APL Research Center

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