Health Condition 1: null- Ovarian cancer
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride Liposome Injection (20mg/10mL): Manufactured by Mylan Laboratories Limited, India
Dosing:Subjects will receive 50 mg/m2 dose of Doxorubicin Hydrochloride lipo
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Non-smoker, female, having a Body Mass Index (BMI) atleast 17 2 Patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start Doxorubicin Hydrochloride liposomal injection. 3 Patients with life expectancy of at least 3 months. 4 Adequate hemopoeitic, renal and liver function. 5 Sexually active women, unless surgically sterile or postmenopausal.
Exclusion criteria
Exclusion criteria: 1 History of allergy or hypersensitivity reactions to Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride Liposome Injection or any related compound at any dose or other anthracycline drugs, or granisetron or dexamethasone. 2 Patients who require a dose reduction to below 50mg/m2. 3 Prior history of acute infusion related reaction. 4 Prior Doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment. 5 Patient having active opportunistic infection or other clinically significant infection 6 Patients with history of other clinically significant concomitant disease. 7 Participation in another clinical trial within 60 days prior to first day of dosing of Investigational Medicinal Product. 8 Pregnant or breastfeeding female. 9 Patients with any cardiac risks. 10 Patients with hepatic impairment and severe renal impairment. 11 A positive HIV and hepatitis screen. 12 Donation of blood within 90 days prior to receiving the first dose of Investigational Medicinal Product for the current study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare and evaluate the single dose,comparative bioavailability of Doxorubicin Hydrochloride Liposome Inj.(20mg/10mL)Timepoint: Total 25 blood samples in each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of patientsTimepoint: Physical examination will be done at screening and during study period. | — |
Countries
India
Contacts
Public ContactDr Ashoka Kumar Singh
Veeda Clinical Research Pvt. Ltd
Outcome results
None listed