Spots Global Cancer Trial Database for BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
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Trial Identification
Brief Title: BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
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
Study ID: NCT01121406
Conditions
Study Description
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)
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
1230.18.32003 Boehringer Ingelheim Investigational Site, Brussel, , Belgium
1230.18.32004 Boehringer Ingelheim Investigational Site, Edegem, , Belgium
1230.18.32002 Boehringer Ingelheim Investigational Site, Gent, , Belgium
1230.18.32001 Boehringer Ingelheim Investigational Site, Leuven, , Belgium
1230.18.3321A Boehringer Ingelheim Investigational Site, Angers Cedex 9, , France
1230.18.3307A Boehringer Ingelheim Investigational Site, Bordeaux cedex, , France
1230.18.3301A Boehringer Ingelheim Investigational Site, Caen, , France
1230.18.3322A Boehringer Ingelheim Investigational Site, Lille Cedex, , France
1230.18.3313A Boehringer Ingelheim Investigational Site, Lyon, , France
1230.18.3312A Boehringer Ingelheim Investigational Site, Nantes cedex 02, , France
1230.18.3308A Boehringer Ingelheim Investigational Site, Nice cedex, , France
1230.18.3314A Boehringer Ingelheim Investigational Site, Paris Cedex 20, , France
1230.18.3302A Boehringer Ingelheim Investigational Site, Paris, , France
1230.18.3309A Boehringer Ingelheim Investigational Site, Pierre-Bénite cedex, , France
1230.18.3305A Boehringer Ingelheim Investigational Site, Reims cedex, , France
1230.18.3320A Boehringer Ingelheim Investigational Site, Saint-Brieuc cedex, , France
1230.18.3311A Boehringer Ingelheim Investigational Site, Strasbourg, , France
1230.18.3310A Boehringer Ingelheim Investigational Site, Toulouse Cedex 9, , France
1230.18.3315A Boehringer Ingelheim Investigational Site, Vandoeuvre les Nancy cedex, , France
1230.18.42101 Boehringer Ingelheim Investigational Site, Bratislava, , Slovakia
1230.18.42103 Boehringer Ingelheim Investigational Site, Poprad, , Slovakia
1230.18.34006 Boehringer Ingelheim Investigational Site, Badalona, , Spain
1230.18.34001 Boehringer Ingelheim Investigational Site, Barcelona, , Spain
1230.18.34005 Boehringer Ingelheim Investigational Site, Barcelona, , Spain
1230.18.34007 Boehringer Ingelheim Investigational Site, Girona, , Spain
1230.18.34004 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat, , Spain
1230.18.34002 Boehringer Ingelheim Investigational Site, Madrid, , Spain
1230.18.34003 Boehringer Ingelheim Investigational Site, Madrid, , Spain
1230.18.46005 Boehringer Ingelheim Investigational Site, Linköping, , Sweden
1230.18.46001 Boehringer Ingelheim Investigational Site, Stockholm, , Sweden
1230.18.46003 Boehringer Ingelheim Investigational Site, Uppsala, , Sweden
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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