Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride Liposome Injection
(LC-101) of Ayana Pharma Ltd: Dose: 2 mg/mL (50 mg/meter square dose)
Duration of treatment: 60 minutes
Control Intervention1: Doxorubicin Hydrochloride Liposome Injection of Sun Pharma Global: Dose: 2 mg/mL (50 mg/meter square dose)
Duration of treatment: 60 minutes
Sponsors
Ayana Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 Injection. 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.
Exclusion criteria
Exclusion criteria: 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 disease. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the bioequivalence and the safety of LC-101 (TEST Product) in comparison to the US Reference standard (REFERENCE product) in subjects with ovarian cancer.Timepoint: Throughout 14 days after both dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed