Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients With Ovarian Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2016

Conditions
Ovarian Cancer
Interventions
DRUG

Doxorubicin hydrochloride liposome

50mg/m2,IV on day1 of each cycle,On Day 1 of Cycle 2, patients will crossover to the alternate reference or test formulation,After completion of Cycle 2 (Day 28), patients will be continued on the treatment of Doxorubicin Hydrochloride Liposome Injection up to 4 more cycles if tolerance permits under guidance of their attending physicians.

Trial Locations (3)

100021

Cancer Institute& Hospital, Chinese Academy of Medical Sciences, Beijing

250012

QiLu Hospital of Shandong University, Jinan

510060

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

INDUSTRY

NCT02237690 - Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients With Ovarian Cancer | Biotech Hunter | Biotech Hunter