Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
Ovarian Epithelial Cancer Recurrent
About this trial
This is an interventional treatment trial for Ovarian Epithelial Cancer Recurrent
Eligibility Criteria
Inclusion Criteria:
- Female of Indian Nationality , between 18-60n years of age
- Able to understand investigational nature of this study and give written informed consent prior to the participation in the trial.
- 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 reference listed drug
- ECOG performance status ≤ 2
- Cardiac function ( LVEF) ≥ 50%
- patient with life expectancy of at least 3 months
- Adequate hematopoietic, renal and liver function
Exclusion Criteria:
- Prior doxorubicin exposure that would result in a total lifetime exposure of 550mg/m2 or more after four cycles of treatment .
- Pregnant or breast-feeding female
- active opportunistic infection with mycobacteria , cytomegalovirus , toxoplasma
Impaired cardiac function including any of the following conditions within past 6 months :
- Unstable angina
- QTc prolongation or other significant ECG abnormalities
- Coronary artery bypass graft surgery
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCl or the components of Doxorubicin Hydrochloride liposome injection.
- known brain metastasis
- HIV positive antibody or syphilis
- Patients with significantly impaired hepatic function
- Clinically significant liver and kidney disease
Sites / Locations
- City Cancer Center
- Nirmal Hospital Pvt Ltd
- Srinivasam Cancer Care Hospitals India Private Limited
- Erode Cancer Center
- Cancer Clinic and Nursing Home & Jasleen Hospital
- Curie Manavta Cancer Centre
- Acharya HariHar Regional Cancer Centre
- Meenakshi Mission Hospital & Research Centre
- Dr. G. Viswanathan Speciality Hospitals
- Bibi General Hospital
- MNJ Institute of Oncology & Regional Cancer Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Test Product - T
Reference Product - R
doxorubicin hydrochloride liposome ( Dr. Reddy's Lab ) Use the test drug (doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Dr.Reddy's Laboratories Ltd., India) ; then use the reference drug ( doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Sun Pharma ) after at least 4-weeks.
doxorubicin hydrochloride liposome ( Sun Pharma ) Use the reference drug (doxorubicin Hydrochloride Liposome Injection 20mg/10mL i.e. 2mg/mL; from Sun Pharma ) ; then use the test drug ( doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Dr.Reddy's Laboratories Ltd., India) after at least 4 weeks.