Please select the arm or intervention descriptions that belong to the clinical trial below.
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
Brief Summary: 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)


Options:
A: Arm Label: BI 6727; Type: EXPERIMENTAL; Interventions: Drug: BI 6727 | Arm Label: Cytotoxic; Type: ACTIVE_COMPARATOR; Interventions: Drug: Paclitaxel, Drug: Gemcitabine, Drug: Topotecan, Drug: Pegylated liposomal doxorubicin (PLD) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Cytotoxic | Intervention Type: DRUG; Name: Gemcitabine; Assigned to Arm(s): Cytotoxic | Intervention Type: DRUG; Name: Topotecan; Assigned to Arm(s): Cytotoxic | Intervention Type: DRUG; Name: Pegylated liposomal doxorubicin (PLD); Assigned to Arm(s): Cytotoxic | Intervention Type: DRUG; Name: BI 6727; Assigned to Arm(s): BI 6727
B: Arm Label: Telcyta + Liposomal Doxorubicin; Type: EXPERIMENTAL; Interventions: Drug: Telcyta, Drug: Liposomal Doxorubicin | Arm Label: Liposomal Doxorubicin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Liposomal Doxorubicin | Intervention Type: DRUG; Name: Telcyta; Assigned to Arm(s): Telcyta + Liposomal Doxorubicin | Intervention Type: DRUG; Name: Liposomal Doxorubicin; Assigned to Arm(s): Liposomal Doxorubicin, Telcyta + Liposomal Doxorubicin
C: Arm Label: Ixabepilone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ixabepilone | Arm Label: Ixabepilone + Bevacizumab; Type: EXPERIMENTAL; Interventions: Drug: Ixabepilone, Drug: Bevacizumab | Intervention Type: DRUG; Name: Ixabepilone; Assigned to Arm(s): Ixabepilone, Ixabepilone + Bevacizumab | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): Ixabepilone + Bevacizumab
D: Arm Label: Arm A: Chemotherapy + Bevacizumab + Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Bevacizumab, Drug: Chemotherapy, Drug: Placebos | Arm Label: Arm B: Chemotherapy + Bevacizumab + Atezolizumab; Type: EXPERIMENTAL; Interventions: Drug: Bevacizumab, Drug: Atezolizumab, Drug: Chemotherapy | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): Arm A: Chemotherapy + Bevacizumab + Placebo, Arm B: Chemotherapy + Bevacizumab + Atezolizumab | Intervention Type: DRUG; Name: Atezolizumab; Assigned to Arm(s): Arm B: Chemotherapy + Bevacizumab + Atezolizumab | Intervention Type: DRUG; Name: Chemotherapy; Assigned to Arm(s): Arm A: Chemotherapy + Bevacizumab + Placebo, Arm B: Chemotherapy + Bevacizumab + Atezolizumab | Intervention Type: DRUG; Name: Placebos; Assigned to Arm(s): Arm A: Chemotherapy + Bevacizumab + Placebo

Answer: A