Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

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 injection therapy .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Doxorubicin; Liposomal doxorubicin

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 :

1. Unstable angina

2. QTc prolongation or other significant ECG abnormalities

3. 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