Ovarian Neoplasms Clinical Trial
Official title:
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
This is an international, randomized phase II trial. The aim is to assess the efficacy and
the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent
third and fourth lines platinum resistant/refractory ovarian cancer.
100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50
patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be
continued until disease progression or unacceptable toxicity. Primary endpoint: disease
control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version
1.1.
Secondary endpoints: efficacy (progression free survival, overall survival, biological
tumour response, biological progression free survival assessed by serum CA 125 according to
Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease
symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms
questionnaires, pharmacokinetics of BI 6727.
Others endpoints: biomarkers and pharmacogenetics analysis (optional)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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