Phase II trial of BI 6727 versus investigator’s choice in patients with cancer of the ovary that did not respond to platinum-based therapy administered before.

Phase 1

• Conditions: Recurrent ovarian cancer resistant or refractory to platinum compounds; MedDRA version: 14.1Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10058448Term: Peritoneal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-015770-35-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-30
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

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 > 4 weeks and = 24 weeks after the final dose of primary or subsequent platinum-based therapy including a minimum of 4 cycles or platinum-refractory disease (disease progression during primary or subsequent platinum-based therapy (up to 4 weeks after final dose). Stable disease as best response to primary or subsequent Platinum-based therapy including minimum of 4 cycles )
- 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: 0
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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified