Multicenter, randomised, double-blind Phase III trial to investigate the efficacy and safety of BIBF 1120 in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in patients with advanced ovarian cancer - BIBF 1120 or placebo in combination with standard chemotherapy in advanced ovarian cancer

Phase 1

Conditions: Advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer
MedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancer
MedDRA version: 9.1Level: LLTClassification code 10016180Term: Fallopian tube cancer
MedDRA version: 9.1Level: LLTClassification code 10026469Term: Malignant neoplasm of specified parts of peritoneum
MedDRA version: 9.1Level: LLTClassification code 10026340Term: Malignant neoplasm of peritoneum, unspecified

Registration Number: EUCTR2008-006831-10-FI

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 1300

Inclusion Criteria

- first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
- FIGO-Stages IIB – IV
- females, age 18 years or older
- life expectancy of at least 6 months
- ECOG performance status 0, 1 or 2
- prior surgery, defined as either (a) debulking surgery with maximum surgical effort at cytoreduction with the goal of no residual disease or (b) biopsy or limited surgery in patients with stage IV disease for whom surgical debulking was not considered appropriate, if diagnosis is confirmed by histology and no surgery is planned prior to disease progression (including interval debulking surgery)
- patient has given written informed consent which must be consistent with the International Conference on Harmonization – Good Clinical Practice (ICH-GCP) and local legislation
- planned application of first dose of chemotherapy after wound healing, but no later than 10 weeks after surgery

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

- histologic diagnosis of a benign or borderline tumour or of a malignant tumour of non-epithelial origin of the ovary, the fallopian tube or the peritoneum
- planned surgery within 124 weeks after randomisation in this trial, including interval debulking surgery
- clinically relevant non-healing wound, ulcer (intestinal tract, skin) or bone fracture
- clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration
- brain metastases
- pre-existing sensory or motor neuropathy CTCAE grade 2 or higher, except due to trauma
- history of major thromboembolic event
- known inherited or acquired bleeding disorder
- significant cardiovascular diseases
- clinically relevant pericardial effusion
- history of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months
- inadequate safety laboratory values
- serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including hepatitis B, hepatitis C, HIV
- poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy
- gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
- other malignancy diagnosed within the past 5 years. In exception to this rule, the following malignancies may be included: (a) non-melanomatous skin cancer (if adequately treated), (b) cervical carcinoma in situ (if adequately treated), (c) carcinoma in situ of the breast (if adequately treated), (d) prior or synchronous low risk endometrial cancer (if adequately treated)
- prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy)
- prior systemic cytotoxic chemotherapy
- prior treatment with BIBF 1120 or any other angiogenesis inhibitor
- prior radiotherapy
- serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease or a laboratory abnormality that may increase the risk associated with study participation or study drug administration
- Women of childbearing potential who are sexually active and not using a highly effective method of birth control during the trial and for at least twelve months after the end of active therapy.
- pregnancy or breast feeding
- psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
- active alcohol or drug abuse
- patients unable to comply with the protocol
- any contraindications for therapy with paclitaxel or carboplatin
- treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial