Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL), of Intas
pharmaceuticals Ltd.: Dose: 50 mg/meter square
Mode of
Administration: Intravenous Infusion
Duration of treatment: Single Dose
Control Intervention1: Doxorubicin Hydrochloride Liposome Injection, 20 mg/ 10 mL (2 mg/mL) of Sun Pharmaceutical Ind. Ltd: Dose: 50 mg/meter square
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients between 18-75 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 with Ovarian Cancer whose disease has progressed or recurred after Platinum-based Chemotherapy and who are already receiving or scheduled to start the therapy with Doxorubicin Hydrochloride Liposome Injection, 20 mg/ 10 mL (2 mg/mL). 5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. 6. Cardiac function (left ventricular ejection fraction [LVEF] greater than or equal to 50 percentage. 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 the opinion of 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/meter square 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 Hydrochloride or the components of Doxorubicin Hydrochloride liposome injection. 7. Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug addiction. 8. Known brain metastasis. 9. Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade 2 by NCI criteria. 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. Patients tested positive for HIV 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 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 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. 18. Patients who are smokers or tobacco users in any form. 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. 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. 21. Patients must not have taken any potent CYP3A4 inhibitors/inducers less than 30 days prior to enrolment including but not limited to: Ketoconazole, Itraconazole, Troleandomycin, Clarithromycin, Erythromycin, Ritonavir, Indinavir, Nelfinavir, Saquinavir, Amprenavir, Nefazodone, Fluvoxamine, Diltiazem, Verapamil, Mibefradil, Cimetidine, Cyclosporine, Grapefruit Juice and pomelocontaining food or fluids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of bioequivalence of the sponsorâ??s test product [Doxorubicin Hydrochloride liposome injection, 20 mg/10 mL (2 mg/mL) relative to that of reference product [Doxorubicin Hydrochloride liposome injection, 20 mg/10 mL (2 mg/mL) in ovarian cancer patients.Timepoint: Period-1 Day 1, 2, 3, 4, 6, 8 10, 12, 14 and 16 Period-2 Day 29, 30, 31, 32, 34, 36, 38, 40, 42 and 44 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the patients, who are exposed to the Investigational Medicinal ProductsTimepoint: Day 1 of period 1 to end of the study | — |
Countries
India
Contacts
Public ContactMr Harshvardhan Shrivastava
Lambda Therapeutic Research Ltd
Outcome results
None listed