NCT01121406

BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Ovarian Neoplasms

Interventions

Type	Name	Description
DRUG	Paclitaxel	Patients receive paclitaxel in a 4 week schedule
DRUG	Gemcitabine	Patients receive gemcitabine in a 3 week schedule
DRUG	Topotecan	Patients receive topotecan in 3 or 4 week schedule
DRUG	Pegylated liposomal doxorubicin (PLD)	Patients receive PLD in a 4 week schedule
DRUG	BI 6727	Patients receive BI 6727 infusion every 3 weeks

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-05-12
• Last updated: 2015-08-13
• Results posted: 2015-08-13

Locations

31 sites across 5 countries: Belgium, France, Slovakia, Spain, Sweden