CT-2106 for the Second Line Treatment of Ovarian Cancer

Inclusion Criteria:

* Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen
* Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
* At least one measurable lesion according to RECIST
* ECOG performance status 0 or 1
* at least 18 years old
* Adequate haematological function
* Adequate renal and hepatic functions
* Normal coagulation parameters

Exclusion Criteria:

* Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of \> 12 months
* Pregnant or lactating patients
* Prior treatment with camptothecins
* Presence or history of CNS metastasis or carcinomatous leptomeningitis;
* Current active infection per investigator assessment;
* Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
* Current history of chronic diarrhea \>= grade 1 (CTCAE version 3);
* Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed;
* Other uncontrolled, serious illness or medical condition, as determined by the investigator;
* Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation;
* Concurrent treatment with any other anti-cancer therapy;
* Known HIV positivity or AIDS-related illness;
* Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.