Health Condition 1: null- Ovarian Cancer
Conditions
Interventions
Intervention1: Cipla Doxorubicin Liposome: Doxorubicin Hydrochloride Liposome Injection 2 mg/mL: 50mg/m2 Frequency: Once a cycle Route of administration: IV Total duration of therapy: 2 cycles
Control
Sponsors
Cipla Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 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 histopathologically/cytologically confirmed Ovarian Cancer requiring Doxorubicin treatment. 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] >=50%. 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 bone marrow, Renal and Liver function. 11. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. It is investigatorâ??s responsibility to ensure that, above points regarding an effective method of avoiding pregnancy, are discussed with patient in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol. 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.Impaired cardiac function within past 6 months 5.History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin HCl or the components of Doxorubicin Hydrochloride liposome injection. 6.Use of any recreational drugs or history of drug addiction 7.Known history of brain metastasis. 8. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI criteria. 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 or HCV antibodies. 11.A positive test result for HIV antibody. 12.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). 13.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 14.Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine. 15.Uncontrolled hypertension. 16.History of cerebrovascular accident (CVA), MI within 06 months or venous thrombosis within 12 weeks. 17.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. 18.Patients must not have taken any potent CYP3A4 inhibitors/inducers <= 14 days prior to enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish bioequivalance between Cipla product and comparatorTimepoint: 2 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients who are exposed to the Investigational Medicinal ProductTimepoint: 2 cycles | — |
Countries
India
Contacts
Public ContactDr Piyush Agarwal
Cipla Ltd
Outcome results
None listed