LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer

Inclusion criteria:

first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
International Federation of Gynecology and Obstetrics (FIGO) Stages IIB - IV
females, age 18 years or older
life expectancy of at least 6 months
Eastern Cooperative Oncology Group (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

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 or bone fracture
clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration
brain metastases
pre-existing sensory or motor neuropathy Common Terminology Criteria for Adverse Events (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, Human Immunodeficiency Virus (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 if adequately treated: non-melanomatous skin cancer, cervical carcinoma in situ, carcinoma in situ of the breast, low risk endometrial cancer
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