A Phase 3, Randomized, Open-Label, Comparative Bridging Study of CAELYX® Versus Topotecan HCl in Subjects With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
This is an open-label (all people know the identity of the intervention), randomized (the
study medication is assigned by chance), comparative bridging study (a supplemental study
which performs to provide data of effectiveness, safety, and dosage to compare two study
medications in a new region). The study consists of 3 phases: screening phase (30 days
before administration of study medication), treatment phase (24 weeks), and survival follow
up phase (every 3 months, up to 1 year after the last dose of the study medication). In the
treatment phase, approximately 120 eligible participants will be categorized prospectively
for platinum-sensitivity (sensitive versus refractory) and bulky disease (presence versus
absence). Later on participants will be randomly assigned either to experimental arm
(CAELYX: administer on Day 1 of six 4-weeks cycles) or control arm (topotecan HCl:
administer on Day 1 to Day 5 of eight 3-weeks cycles). Safety evaluations will include
assessment of adverse events, clinical laboratory tests, electrocardiogram, echocardiogram,
vital signs, and physical examination which will be monitored throughout the study. The
total duration of the study will be approximately 19 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate at Week 24
Progression-free survival rate will be measured as number of participants who are progression-free and alive.
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
Xian-Janssen Pharmaceutical Ltd.
China: Food and Drug Administration