Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride Liposome Injection 20 mg/10mL (2 mg/mL) of Cadila Healthcare Limited: Dose: 50 mg/m2
Mode of Administration:intravenously
Duration of treatment: 28 days
Control Intervention1: Doxorubicin Hydrochloride Liposome Injection20 mg/10 mL (2 mg/mL) of Sun Pharmaceutical Ind. Ltd: Dose: 50 mg/m2
Duration of treatment: 28 days
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients between 18-65 years of age (Both Inclusive). 2. Patients must be able to understand the investigational nature of this study and to give written informed consent prior to the participation in the trial. 3. Patients with confirmed Ovarian Cancer requiring Doxorubicin 4. Patient of Ovarian Cancer whose disease has progressed or recurred after Platinum-based Chemotherapy and who are already receiving or scheduled to start the therapy with the Doxorubicin. 5. Eastern Cooperative Oncology Group (ECOG) performance status 6. Cardiac function (left ventricular ejection fraction [LVEF] 7. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator. 8. Patients with life expectancy of at least 3 months. 9. Able to comply with study requirement in opinion of Principal Investigator. 10. Adequate hematologic status, Renal and Liver function. 11. Females of reproductive potential must use an acceptable and effective method of avoiding pregnancy, starting at least four weeks before the first dose of study drug and continuing until at least one month after the last dose of study drug. 12. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of minor surgery; at least 4 weeks must have elapsed from the time of major surgery.
Exclusion criteria
Exclusion criteria: 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 or kidney function. 5. Impaired cardiac function 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. Pre-existing motor or sensory neurotoxicity of a severity 10. Other serious illness or medical condition that would prohibit the understanding and giving of informed consent 11. A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies. 12. A positive test result for HIV antibody and/or syphilis. 13. The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior to the first dose of investigational Product (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study). 14. Any other condition/Abnormal baseline that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study 15. Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine. 16. Uncontrolled hypertension (systolic blood pressure [BP] >180 or diastolic BP >100mm Hg) or uncontrolled cardiac arrhythmias (Patients with hypertension controlled by antihypertensive therapies are eligible). 17. History of cerebrovascular accident (CVA), MI within 06 months or venous thrombosis within 12 weeks. (Patients with previous history of venous thrombosis on a stable dose of anticoagulation are allowed.) 18. Past or current history of neoplasm other than the Ovarian Cancer and with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix. 19. Females of reproductive potential unwilling to use acceptable contraception (as defined in the protocol) throughout the trial and for one month after the last dose of study medication. 20. Patients must not have taken any potent CYP3A4 inhibitors/inducers enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterization of pharmacokinetic profile and to assess the bioequivalence of the sponsorâ??s test product relative to that of reference product in ovarian cancer patientsTimepoint: Before start of infusion, During infusion (0.083 h to 0.750 h), End of infusion (1 h, 1.250, 1.500, 6.000, 8.000, 12.000, 216.000, 264.000 and 336.000 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| safety of the patientsTimepoint: From the time of first administration of study drug until Study Completion | — |
Countries
India
Contacts
Public ContactMr Tapan Shah
Lambda Therapeutic Research Ltd
Outcome results
None listed