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

Phase 3

Completed

Conditions: advanced ovarian cancer
10038594

Registration Number: NL-OMON32516

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1) first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
2) FIGO) Stages IIB - IV
3) females, age 18 years or older
4) life expectancy of at least 6 months
5) ECOG performance status 0, 1 or 2
6) prior debulking surgery with maximum surgical effort at cytoreduction with the goal of no residual disease, or 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)
7) planned application of first dose of chemotherapy after wound healing, but no later than 10 weeks after surgery

Exclusion Criteria

1) 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
2) planned surgery within 124 weeks after randomisation in this trial, including interval debulking surgery
3) clinically relevant non-healing wound, ulcer or bone fracture
4) clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration
5) brain metastases
6) pre-existing sensory or motor neuropathy CTCAE grade 2 or higher, except due to trauma
7) history of major thromboembolic event
8) known inherited or acquired bleeding disorder
9) significant cardiovascular diseases
10) clinically relevant pericardial effusion
11) history of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months
12) inadequate safety laboratory values
13) serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV)
14) poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy
15) gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
16) 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
17) prior systemic therapy for ovarian cancer, prior systemic cytotoxic chemotherapy, radiotherapy or prior treatment with BIBF 1120 or any other angiogenesis inhibitor
18) Pregnant, breast feeding, or women of childbearing potential who do not use a highly effective method of birth control during the trial and for at least twelve months after the end of active therapy.
19) active alcohol or drug abuse
20) any contraindications for therapy with paclitaxel or carboplatin
21) 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