Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy
1. Confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian
2. Platinum resistant or platinum refractory disease.
3. Eastern Collaborative Oncology Group performance status < = 2.
4. Life expectancy > = 3 months.
5. At least one measurable lesion (Response Evaluation Criteria In Solid Tumours version
6. Adequate hepatic, renal and bone marrow functions.
7. signed written informed consent prior to admission to the study.
1. Contre-indications for cytotoxic treatment according to the Summary of Product
Characteristics (Arm B).
2. Clinical evidence of active brain metastasis or leptomeningeal involvement.
3. Other malignancy currently requiring active therapy.
4. QTc prolongation according to Fridericia formula deemed clinically relevant by the
investigator (e.g., congenital long QT syndrome, QTc according to Fridericia formula
> 470 ms).
5. Hypersensitivity to one of the trial drugs or the excipients.
6. Serious illness or concomitant non- oncological disease.
7. Systemic anticancer therapy within 4 weeks before the start of the study.
8. Evidence of ileus sor sub ileus.