Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for solution for
infusion 20 mg/10mL (2 mg/ml) by Dr. Reddyâ??s Laboratories Ltd, India: Dose: Single dose of 50 mg/m2 from 2
Frequency: Once in every 28 days (1 Cycle)
Mode of administration: IV infusion
Duration: 28 days
Control Intervention1: Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for
solution for infusion (20
mg/10mL)] by Janssen-Cilag International NV, Belgiu
Duration: 28 days
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Females of age between 18-65 years (both inclusive). 2. Able to understand the investigational nature of this study and give written informed consent prior to the participation in the trial. 3. Subject with advanced ovarian cancer requiring Doxorubicin and who have failed a first-line platinum-based chemotherapy regimen (Disease progression / reoccurrence after platinum based chemotherapy). Or As monotherapy for subjects with metastatic breast cancer 4. Cardiac function (left ventricular ejection fraction [LVEF] >=50%. 5. Subject should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator. 6. Subject with life expectancy of at least 3 months. 7. Able to comply with study requirement in opinion of Principal Investigator. bin 8. 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. 9. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must have negative pregnancy test at screening as well as prior to check-in and must agree to 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 subject in detail and subject agreed for this and it is documented in source document. The investigator should ensure that the subject is using an effective method of avoiding pregnancy as per protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects who are pregnant or breast feeding. 2. Subjects with an ECOG (Eastern Cooperative Oncology group) Performance Status Score > 3. 3. Subject who had received prior treatment with any liposomal doxorubicin injection. 4. If total cumulative dose of Doxorubicin HCl approaches 450 mg/m2. 5. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.carinii or other microorganism if under treatment with myelotoxic drugs. 6. Any other clinically significant liver or kidney disorders other than mentioned in the selection criteria. 7. Impaired cardiac function including any of the following conditions within past 6 months: a. Unstable angina. b. QTc prolongation or other significant ECG abnormalities. c. Coronary artery bypass graft surgery. d. Symptomatic peripheral vascular disease. e. Myocardial infarction. f. NYHA class II-IV heart failure. g. Severe uncontrolled ventricular arrhythmias. h. Clinically significant pericardial disease. i. Electrocardiographic evidence of acute ischemic or active conduction system abnormalities. j. Subjects with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if their disease has been stable for the past six months. k. Severe uncontrolled arrhythmias. 8. History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride Liposome (Pegylated Liposomal). 9. Use of any recreational drugs or history of drug addiction. 10. Known brain metastasis. 11. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI criteria. 12. Other serious illness or medical condition that would prohibit the understanding and giving of informed consent. 13. A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies. 14. A positive test result for HIV antibody and/or syphilis (VDRL). 15. The receipt of an investigational product, or participation in a drug research study within a period of 90 days prior to the first dose of investigational Product. 16. Any other condition that, in the investigatorâ??s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 17. Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints. 18. Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures. 19. History of donation of blood/loss of blood (without replenishment) (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study. 20. Uncontrolled hypertension (systolic blood pressure [BP] >160 or diastolic BP >100mm Hg) or uncontrolled cardiac arrhythmias (Subjects with hypertension controlled by antihypertensive therapies are eligible). 21. History of cerebrovascular accident (CVA), MI within 6 months or venous thrombosis within 12 w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of the Test Product relative to that of Reference Product in advanced ovarian cancer and/or metastatic breast cancer patients under fed conditionsTimepoint: Day 1 and Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients, who are exposed to the Investigational Medicinal ProductTimepoint: Day 1, Day 28 and Day 57. | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Lambda Therapeutic Research Ltd
Outcome results
None listed