Health Condition 1: null- Advanced ovarian cancer and/or metastatic breast cancer
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride Liposomal Injection: single dose vials of 20 mg/10mL (2mg/ml) Dose50 mg/m2,
Frequency In every 28 days (1 cycle),Mode of Administration IV
Control Interventio
Sponsors
Teva Pharmachemie
Lotus Labs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female patient >= 18 and 2.Having a Body Mass Index (BMI) of at least 17 calculated as weight in kg / height in m2 and the Body Surface Area (BSA) not to exceed 1.79 m2. 3.Able to understand the investigational nature of this study and give written informed consent prior to the participation in the trial. 4.Patients with advanced ovarian cancer requiring Doxorubicin and who have failed a first-line platinum-based chemotherapy regimen. OR As monotherapy for patients with metastatic breast cancer 5.Patients with life expectancy of at least 6 months as judged by the investigator. 6.Adequate hematopoietic, renal and liver function. Body system Parameters Bone marrow function Absolute neutrophil count >= 1500/mm3 Platelet count >= 100,000/mm3 Haemoglobin >= 9.0 g/dl Renal function Serum Creatinine Hepatic function AST and ALT Bilirubin 7.Have a baseline LVEF by ECHO/MUGA >= 50% 8.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator. 9.Discontinued all steroids and all anti-convulsive agents for at least three months since definitive treatment of their brain metastases (for patients with previously diagnosed brain metastases) 10.Have an ECOG PS of 0-2, inclusively 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. 12.Able to comply with study requirement in opinion of Principal Investigator
Exclusion criteria
Exclusion criteria: The patient will not be eligible to participate in the study if ANY of the below criteria is met: 1.HIV/HBsAg (including B and C virus)/Syphilis positive. 2.History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin HCl or the components of Doxorubicin Hydrochloride liposome injection. 3.Prior dose limiting toxicity on Pegylated Liposomal Doxorubicin at 50 mg/m2 4.Total cumulative doses of doxorubicin hydrochloride approach 450 mg/m2 including the three cycles considered for this study. 5.Pregnant or breast feeding women 6.Received the standard chemotherapy within the past 28 days prior to the start of first dosing for the study. (Note: Sufficient washout period to be maintained depending on the molecule For eg. 28 days for Doxorubicin, 6 weeks for mitomycin C and nitrosureas, 21 days for paclitaxel etc.) 7.Has undergone prior radiation therapy within the past 14 days prior to the start of first dosing for the study. 8.Has undergone a major surgical procedure within 28 days of the start of first dosing for the study. Minor procedures such as biopsies or port placements are allowed as long as the patient has recovered. 9.Has an active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P. carinii, or other microorganism if under treatment with myelotoxic drugs 10.Has impaired cardiac function including any of the following conditions within past 6 months (To be judged based on the discretion of Investigator): a)Unstable angina b)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) k)Severe uncontrolled arrhythmias 11.Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints 12.Has history of consumption of excessive amounts of alcohol (greater than two drinks per day) or use of any recreational drugs or history of drug addiction 13.Uncontrolled hypertension (systolic blood pressure [BP] >180 or diastolic BP >100mm Hg) (Patients with hypertension controlled by antihypertensive therapies are eligible). 14.Any patient who had donated /or had loss of blood (1 unit or 350ml) within 90 days prior to receiving the first dose for the current study The receipt of an investigational product 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary PK parametersTimepoint: primary PK parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| To summarize the treatment emergent adverse events in patients Timepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDr Anuradha Srikrishna
Lotus Labs Pvt. Ltd
Outcome results
None listed