Recurrent ovarian cancer resistant or refractory to platinum compounds
Conditions
Interventions
Product Code: BI 6727 CL3
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BI 6727 CL3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number:
Sponsors
Boehringer Ingelheim France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Females, age = 18 years - Confirmed epithelial ovarian cancer, peritoneal carcinoma or fallopian tube cancer - Platinum-resistant disease (disease progression within a platinum-free interval of = 6 months after the final dose of primary or subsequent platinum-based therapy) or platinum-refractory disease (disease progression during primary or subsequent platinum-based therapy. Stable disease as best response to primary or subsequent Platinum-based therapy ) - The patient has completed at least two and up to three chemotherapy regimens for the management of this condition, one of which may have been treatment for platinum resistant or refractory disease. Treatment may have included intraperitoneal therapy, consolidation or extended therapy after surgical or non surgical assessment. - ECOG performance status = 2 - Life expectancy = 3 months - At least, one measurable or non-measurable lesion according to RECIST 1.1 - Adequate hepatic, renal and bone marrow functions - Signed and dated written informed consent prior to admission to the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Contre-indications for cytotoxic treatment according to the SPC (Arm B) - Clinical evidence of active brain metastasis or leptomeningeal involvement - Other malignancy currently requiring active therapy - QTcF prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome, QTcF > 470ms etc.) - Hypersensitivity to one of the trial drugs or the excipients - Serious illness or concomitant non-oncological disease - Systemic anticancer therapy within 4 weeks before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Disease Control Rate at week 24;Secondary Objective: - Median Progression Free survival, Overall survival, Best Overall Response, - Safety, - PK study (patients randomized in the BI 6727 arm), - Biomarkers and pharmacogenetics analysis (optional): o PLK1 expression and activity in tumour biopsies and ascites, o PLK1 and MDR1 genetic polymorphisms. ;Primary end point(s): Disease Control rate at week 24 according to RECIST criteria 1.1 | — |
Countries
Belgium, France, Slovakia, Spain, Sweden
Outcome results
None listed