Conditions: Epithelial Ovarian Cancer
Keywords: second line treatment platinum resistant ovary ovaries cancer epithelial carcinomas tumor
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 183
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.

Detailed description:
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.

Arms:
arm 1: All patients will receive voreloxin injection

Interventions: intervention 1: Voreloxin Injection
Intervention descriptions: intervention 1: All patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.

Protocol document: