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 - ND

Phase 1

• Conditions: patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer; MedDRA version: 9.1Level: LLTClassification code 10033128; MedDRA version: 9.1Level: LLTClassification code 10016180; MedDRA version: 9.1Level: LLTClassification code 10026469; MedDRA version: 9.1Level: LLTClassification code 10026340

• Registration Number: EUCTR2008-006831-10-IT
• Lead Sponsor: BOEHRINGER ING.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-21
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1400

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 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); 7.Patient has given written informed consent which must be consistent with the International Conference on Harmonization Good Clinical Practice (ICH-GCP) and local legislation; 8.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

1.Histologic diagnosis of a benign or borderline tumour (tumour of low malignant potential) or of a malignant tumour of non-epithelial origin (e.g. germ cell tumour, sex cord-stromal tumour) 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 (intestinal tract, skin) or bone fracture; 4.Clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration; 5.Clinical symptoms of brain metastases or diagnosis of brain metastases on imaging; 6.Pre-existing sensory or motor neuropathy CTCAE >=2, except due to trauma; 7.History of major thromboembolic event (see protocol section 3.3.2); 8.Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy (including deficiency of antithrombin, deficiency of protein C or protein S, Factor V Leiden mutation, Prothrombin G20210A mutation); 9.Known inherited or acquired bleeding disorder 10.Significant cardiovascular diseases (see protocol section 3.3.2); 11.Clinically relevant pericardial effusion (e.g. pericardial effusion with echocardiographic or clinical signs of haemodynamic impairment); 12.History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months; 13.Laboratory values indicating an increased risk for adverse events (see protocol section 3.3.2); 14.Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including (a) hepatitis B and/or C infection (b) HIV-infection; 15.Poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy; 16.Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug; 17.Other malignancy diagnosed within the past 5 years. For the exception see protocol section 3.3.2; 18.Prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy); 19.Prior systemic cytotoxic chemotherapy; 20.Prior treatment with BIBF 1120 or any other angiogenesis inhibitor; 21.Prior radiotherapy (a) to the abdomen or (b) to an extra-abdominal target volume that would bear the risk of increased toxicity of chemotherapy; 22.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 and in the judgment of the investigator would make the patient inappropriate for entry into the study; 23.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; 24.Pregnancy or breast feeding; 25.Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule; 26.Active alcohol or drug abuse; 27.Patients unable to comply with the protocol; 28.Any contraindications for therapy with paclitaxel or carboplatin, e.g. a history of severe hypersensitivity reactions to paclitaxel or platinum-containing compounds and their excipients, or other drugs formulated with Polyoxyl 35 Castor Oil-ELP; 29.Treatment with other investigational drugs or participation in a

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether BIBF 1120 in combination with the standard chemotherapy of paclitaxel and carboplatin in patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer is more effective than placebo in combination with standard chemotherapy of paclitaxel and carboplatin.;Secondary Objective: -Progression free survival according to modified RECIST-1.1 (key secondary endpoint). -Overall survival (OS). -Time to tumour marker progression (CA-125). -Objective response in patients with surgeon`s assessment of macroscopic residual tumour after surgery and tumour lesions on baseline CT;Primary end point(s): The primary endpoint for efficacy is progression free survival. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death.