Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride pegylated liposomal 2 mg/ml concentrate for solution for infusion (20 mg/10 ml) of TTY Biopharm Company Ltd., Taiwan: Single dose of Doxorubicin
Hydrochloride
Sponsors
TTY Biopharm Company Ltd
Veeda Clinical Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients between 18-65 years of age (both inclusive). 2. Ability to understand and provide written informed consent given before the initiation of the pre-study screening prior to participation in the study. 3. Patients with advanced ovarian cancer who have failed a first-line platinum-based chemotherapy regimen And/or Patients with metastatic breast cancer who require Doxorubicin Hydrochloride (Pegylated liposomal) for treatment that are already receiving or scheduled to start Doxorubicin Hydrochloride (Pegylated liposomal) in the dose of 50 mg/m2 dose as monotherapy. 4. Cardiac function (left ventricular ejection fraction [LVEF]) ââ?°Â¥50%. 5. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator. 6. Patients with life expectancy of at least 6 months. 7. Able to comply with study requirement in opinion of Principal Investigator. 8. Adequate Hematopoietic, Renal and Liver function defined as the following: Bone marrow function: ANC more than or equal 1500/mm3 Platelet count more than equal 100,000/mm3 Haemoglobin ââ?°Â¥ 9.0 g/dl Renal function:Serum Creatinine ââ?°Â¤ 1.5 x ULN Hepatic function AST and ALT ââ?°Â¤ 3 x ULN (ââ?°Â¤5Ã?â?? ULN for liver metastasis) Alkaline phosphatase ââ?°Â¤ 2.5 x ULN (ââ?°Â¤5 Ã?â?? ULN for bone metastasis and ââ?°Â¤4 Ã?â?? ULN for liver metastasis) Total Bilirubin 9. 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. 10. 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) during study and up to 6 months after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
Exclusion criteria
Exclusion criteria: 1. Patients who are: â�¢ Pregnant â�¢ Breast feeding â�¢ Of childbearing potential with a positive pregnancy test at screening (serum) and prior to dosing (urine) in Period I. â�¢ Female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial 2. Patients with an ECOG (Eastern Cooperative Oncology group) Performance Status Score >3. 3. If total cumulative dose (lifetime exposure) of Doxorubicin approaches 450 mg/m2. 4. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.carinii or other microorganism if under treatment with myelotoxic drugs. 5. Clinically significant liver or kidney disorders. 6. Patients with severe ascites and pleural exudates. 7. Impaired cardiac function including any of the following conditions within past 6 months: a. Unstable angina b. QTc prolongation ( >450 msec) 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. Patients 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 pegylated liposomal or the components of Caelyx�®. 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 â�¥ 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/RPR) test. 8. History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride pegylated liposomal or the components of Caelyx�®. 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 â�¥ 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/RPR) test. 8. History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride pegylated liposomal or the components of Caelyx�®. 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 â�¥ grade 2 by NCI criteria. 12. Other serious illness or medical condition that would prohibit the unde
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of the sponsorââ?¬â?¢s test productTimepoint: A total of 23 blood samples will be collected during each period. The pre-infusion blood sample of 3.5 mL (0h) will be collected within one hour prior to start of infusion. From the start of infusion i.e. during infusion is ongoing: 0.25h (15 min), 0.5h (30 min), 0.75h (45 min). After completion of infusion: immediately after end of infusion, 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00, 168.00, 336.00 and 504.00 hrs. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients, who are exposed to the Investigational Medicinal ProductTimepoint: study will be of at least 78 Ã?±2 days from the first day of IMP administration in period I till the end of study sample collection in period III on regular intervals as per protocol. | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical Research Ltd
Outcome results
None listed