A multicenter, open label, balanced, randomized, two-treatment, two- period, two-sequence, cross-over bioequivalence study of Pegylated Liposomal Doxorubicin HCl injection IV 2 mg/ mL of Intas Pharmaceuticals Ltd., India, with that of DoxilÂ® 2 mg/mL (Doxorubicin HCl Liposome injection) in ovarian cancer patients whose disease has progressed or recurred after platinum based chemotherapy under fasting condition. - NA

Intas Pharmaceuticals Ltd0 个研究点目标入组 48 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Females of Indian Nationality, between 18-60 years of age.
•2.Able to understand the investigational nature of this study and give written informed consent prior to the participation in the trial.
•3.Patients with Ovarian Cancer requiring Doxorubicin and whose disease has progressed or recurred after Platinum-based Chemotherapy and who are already receiving or scheduled to start therapy with the reference listed drug.
•4.Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
•5.Cardiac function (left ventricular ejection fraction [LVEF] >=50%.
•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 Hemopoeitic, Renal and Liver function.

•1.Pregnant or breast-feeding female.
•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.Significantly impaired hepatic function
•5.Clinically significant liver, kidney or cardiac disease.
•6.History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin HCl or the components of Doxorubicin Hydrochloride liposome injection.
•7.Use of any recreational drugs or history of drug addiction
•8.Known brain metastasis.
•9.Other serious illness or medical condition that would prohibit the understanding and giving of informed consent
•10.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
•11.A positive test result for HIV antibody and/or syphilis.
•12.Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
•13.Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
•14.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.

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