CTRI/2018/07/014835已完成未知
A Randomized, Open Label, Two Arm, Single Dose, Crossover, Bioequivalence Study of Ayana Pharmaâ??s Doxorubicin Hydrochloride Liposome Injection (LC-101) (Investigational Product) and the US Reference Standard DoxorubicinHydrochloride Liposome Injection (SUN Pharma), in Subjects with Ovarian Cancer.
Ayana Pharma Ltd0 个研究点目标入组 52 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 52
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. Adult female subjects between 18 to 65 years of age (both inclusive) at the time of screening visit.
- •2. Subjects with histologically or cytological proven ovarian cancer, whose disease has
- •progressed or recurred after platinum-based chemotherapy and scheduled to start therapy with or who are already receiving an approved dose of 50 mg per meter square Doxorubicin Hydrochloride Liposome Injection product.
- •3. Subjects expected to be able to receive both doses of Doxorubicin Hydrochloride Liposome
- •4. Subjects eligible for receiving a dose of 50 mg per meter square of Doxorubicin Hydrochloride Liposome Injection.
- •5. Subjects with Performance less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
- •6. Cardiac function (LVEF) greater than or equal to 50 percentage.
- •7. Adequate renal, hepatic and bone marrow function without blood product or hematopoietic
- •growth factor support.
- •8. Subjects able to understand the investigational nature of this study.
- •9. Availability of subject for the entire study period and willingness to adhere to protocol
- •requirements.
- •10. For subjects of child-bearing potential, serum beta HCG pregnancy test at screening and urine pregnancy test prior to dosing must be negative and subjects agree to use an acceptable and effective approved method of contraception
- •11. Subjects of non-childbearing potential who are either surgically sterile (hysterectomy,
- •bilateral oophorectomy, or bilateral tubal ligation) or greater than 1 year postmenopausal with follicle stimulating hormone in the postmenopausal range
- •12. Signed written informed consent.
排除标准
- •1. Subjects with history or presence of significant:
- •o Allergy or significant history of hypersensitivity or idiosyncratic reactions to a conventional formulation of Doxorubicin Hydrochloride and/or any components of
- •Doxorubicin Hydrochloride liposome injection.
- •o Clinically significant pulmonary, hepatic, renal, bone marrow, gastrointestinal,
- •endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric
- •o Impaired cardiac function
- •2. Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug
- •within the past one year.
- •3. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, p. carinii or other microorganism (bacterial, viral or fungal).
- •4. Clinically significant illness (except ovarian cancer) within four weeks prior to dosing.
- •5. Prior radiation therapy to mediastinum
- •6. Concomitant use of other cytotoxic or cytostatic drugs or of radiotherapy within four
- •weeks prior to dosing
- •7. Subject under treatment of myelotoxic drugs, other than doxorubicin (liposomal).
- •8. Use of prescription or non-prescription herbal and dietary supplements, within 7 days prior to dosing.
- •9. Subjects with other known active malignancies requiring treatment within 3 years (except for ovarian and/or skin cancer).
- •10. Subjects with known brain metastasis and/or subjects considered for radiotherapy treatment.
- •11. Positive result to any of the following: HIV-1/2, hepatitis A, B and C; syphilis.
- •12. Use of CYP3A4 enzyme-modifying drugs in the previous 30 days prior to dosing and during the study
- •13. Subjects who have:
- •o Systolic blood pressure less than 90 mmHg or more than 160 mmHg
- •o Diastolic blood pressure less than 60 mmHg or more than 95 mmHg
- •o Pulse rate below 55 per min. or above 100 per min
- •14. Subjects with abnormal laboratory parameters
- •15. 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).
- •16. Subjects who are legally detained in an official institute.
- •17. Subjects with prior doxorubicin exposure that would result in a total lifetime exposure of 550 mg per meter square or more after four cycles of treatment.
- •18. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments
- •19. Females of childbearing potential unwilling to use acceptable contraception (as identified in the protocol) throughout the trial and for 6 months after the last dose of study drug.
- •20. Pregnant or breast-feeding subjects.
研究者
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