Status:
COMPLETED
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Ovarian Epithelial Cancer Recurrent
Eligibility:
FEMALE
18-60 years
Phase:
PHASE1
Brief Summary
Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are already receiving or who in the opinion of their treating physicians are candidates for Doxorubicin liposomal ...
Detailed Description
This study has sequential two stage design. Bioequivalence based on encapsulated doxorubicin will be tested at the end of stage 1. Power analysis will be performed for the primary pharmacokinetic para...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT02260544
Start Date
July 1 2014
End Date
August 1 2015
Last Update
September 23 2016
Active Locations (11)
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1
City Cancer Center
Vijaywada, Andhra Pradesh, India
2
Nirmal Hospital Pvt Ltd
Surat, Gujarat, India
3
Srinivasam Cancer Care Hospitals India Private Limited
Bangalore, Karnataka, India
4
Erode Cancer Center
Erode, Karnataka, India