A PHASE 3 STUDY OF SAFETY AND EFFICACY OF KARENITECIN VERSUS TOPOTECAN ADMINISTERED FOR 5 CONSECUTIVE DAYS EVERY 3 WEEKS IN PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER

INTERVENTION: Product Name: Karenitecin Product Code: BNP1350 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: BNP1350 Other descriptive name: Karenitecin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.1‐ Trade Name: Hycamtin Pharmaceutical Form: Powder for concentrate for solution for infusion Other descriptive name: Topotecan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ CONDITION: advanced epithelial ovarian cancer ; MedDRA version: 9.1 Level: LLT Classification code 10066697 Term: Ovarian cancer recurrent PRIMARY OUTCOME: Main Objective: The objective of this study is to determine the safety and efficacy of intravenous karenitecin versus topotecan in patients with platinum/taxane‐resistant advanced epithelial ovarian cancer. Primary end point(s): The primary endpoint will be Progression Free Survival (PFS); defined as the time period from the date of randomization to the date of first radiographical documented progressive disease (PD) or date of death due to any cause, taking the event date that occurs first.; The date of PD will be determined by radiographical objective disease (RECIST) measurement.; Secondary Objective: None INCLUSION CRITERIA: 1. Age = 18 years. 2. Documented histopathological or cytological diagnosis of stage III or IV epithelial ovarian cancer as defined by the International Federation of Gynecology and Obstetrics (FIGO) (Appendix D of the protocol). 3. The following tumor histological epithelial cell types will be accepted: • Serous adenocarcinoma • Endometrioid adenocarcinoma • Mucinous adenocarcinoma • Undifferentiated carcinoma • Clear cell adenocarcinoma • Mixed epithelial carcinoma • Transitional cell carcinoma • Adenocarcinoma (grade = 2) not otherwise specified. 4. Documented resistance to platinum/taxane‐based chemotherapy, as indicated by relapse/progression while on or within 6 months of completion of treatment in a first‐line or second‐line setting; or a best response of stable disease (SD) after 6 cycles of platinum/taxane treatment in the first‐line setting. Platinum/taxane‐based regimens must have included either cisplatin or carbop