Clareo Health | An Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Carboplatin and Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer

Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol

Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy

Serious, non-healing wound, ulcer or bone fracture or major injuries and/or surgery within 4 weeks of trial inclusion, or planned surgical procedures during the trial period.

Investigational drug therapy outside of this trial during or within 4 weeks of study entry

Known hypersensitivity to the trial drugs or their excipients.

History of other malignancies in the last 5 years, in particular those which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.

Serious concomitant disease, especially those that would limit compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial.

Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure \>NYHA II)

Known inherited predisposition to bleeds or to thrombosis.

Patient with brain metastases that are symptomatic and/or require therapy.

Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid ≤ 325mg per day)

History of major thrombotic events or clinically relevant major bleeding event in the past 6 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis below the joint space of the knee)

Current peripheral neuropathy ≥ CTCAE grade 2 except due to trauma

Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug

Active alcohol or drug abuse.

Men who are sexually active and unwilling to use a medically acceptable method of contraception

Leptomeningeal disease

Radiographic evidence of cavitary or necrotic tumours

Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels

An Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Carboplatin and Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer - Stage IV (VENUS-2)

What this study is about