Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride liposome injection 20mg/10mL,Dr. Reddyâ??s Laboratories Ltd, India: Dose - 50 mg/m2,
Frequency - In every 28 days (1 cycle),
Mode of Administration - IV,
Durat
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Females of Indian Nationality, between 18-60 years of age. 2. Able to understand the investigational nature of this study and give written informed consent prior to the participation in the trial. 3. Patients with Ovarian Cancer requiring Doxorubicin and whose disease has progressed or recurred after Platinum-based Chemotherapy and who are already receiving or scheduled to start therapy with the reference listed drug. 4. Eastern Cooperative Oncology Group (ECOG) performance status 5. Cardiac function (left ventricular ejection fraction [LVEF] >=50%. 6. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator. 7. Patients with life expectancy of at least 3 months. 8. Able to comply with study requirement in opinion of Principal Investigator. 9. Adequate Hemopoeitic, Renal and Liver function.
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 5. Clinically significant liver, kidney or cardiac disease. 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. Other serious illness or medical condition that would prohibit the understanding and giving of informed consent 10. A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies. 11. A positive test result for HIV antibody and/or syphilis. 12. Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine. 13. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study. 14. Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a disease free survival >= 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUCTimepoint: 1 hr prior to dosing, During infusion: 0.083, 0.167, 0.333, 0.500 and 0.750 h; end of infusion: 1.000 hr and after end of infusion: 1.250, 2.000, 4.000, 6.000, 12.000, 24.000, 48.000, 120.000, 264.000, 336.000 hr | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety ParametersTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDr Arpit Prajapati
Lambda Therapeutic Research Ltd.
Outcome results
None listed