A Randomized, Open Label, Two Treatments, Two Periods, Two Sequences, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection 2 mg/ml (50mg/m2 dose) of LC-101, Lipocure Ltd (Investigational Product) and Lipodox (Doxorubicin Hydrochloride Liposome Injection), of Sun Pharmaceutical Industries Ltd. (Reference Drug), in patients with Ovarian Cancer

Chaya Mazouz0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Adult female subjects between 18 to 75 years of age at the time of screening visit.
•2.Availability of subject for the entire study period and willingness to adhere to protocol requirements.
•3.Patients with documented diagnosis of Ovarian Cancer whose disease has progressed or recurred after platinum-based chemotherapy.
•4.Subjects eligible for receiving a dose of 50mg/m2 of Doxorubicin liposome (preferably on no other concomitant medication, however, if considered necessary, to be documented and given).
•5.Patients with Performance <= 2 on the ECOG performance scale.
•6.Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance.
•7.Signed written informed consent

•1.History or presence of significant:
•a.Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc.
•b.Clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
•c.Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
•d.Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, p. carinii or other microorganism
•e.Clinically significant illness (except ovarian cancer)within four (4) weeks before the start of the study
•f.Positive result to HIV.
•g.Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study.
•2.Subjects who have:
•h.Systolic blood pressure less than 90 mmHg or more than 160 mmHg
•i.Diastolic blood pressure less than 60 mmHg or more than 95 mmHg
•j.Pulse rate below 60/min. or above 100/min
•3.Subject under treatment of myelotoxic drugs
•4.Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s)
•5.Subjects who are legally detained in an official institute

发起方

Chaya Mazouz