Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors

Inclusion criteria

• Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, and for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
• Age > or = 18 years
• European Cooperative Oncology Group performance status < or = 2
• Written informed consent in accordance with International Conference on Harmonization -Good Clinical Practice (ICH-GCP) and local legislation
• Recovery from Common Terminology Criteria for Adverse Events grade 2-4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapy (except alopecia)

Exclusion criteria

• Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the trial
• Known hypersensitivity to the trial drugs or their excipients
• Treatment with any other investigational drug or participation in any other interventional trial within 28 days before first administration of trial drug (BIBF 1120) or concomitantly with this trial
• Systemic anti-cancer therapy or radiotherapy within 28 days before start of therapy or concomitantly with this trial. The restriction does not apply to steroids and bisphosphonates
• Active infectious disease infection or HIV I/II
• Other malignancy currently requiring another anti-cancer therapy
• Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months
• Known inherited predisposition to bleeding or thrombosis
• Radiographic evidence of cavitary or necrotic tumours
• History of clinically significant haemoptysis within the past 3 months
• Centrally located tumours with radiographic evidence (Computed Tomography or Magnetic Resonance Imaging) of local invasion of major blood vessels
• Absolute Neutrophil Count (ANC) less than 1.5 x 1000000000/L
• Platelets Count (PLT) less than 100 x 1000000000/L
• Total bilirubin > upper limit of normal (ULN)
• Alaninaminotransferase (ALT) and/or Aspartateaminotransferase (AST) >= 1.5 x ULN (in case of liver metastases: ALT and AST >= 2.5 x ULN)
• Serum creatinine > 1.5 mg/dl
• Major injuries and/or surgery or bone fracture within 28 days before first administration of trial drug (BIBF 1120), or planned surgical procedures during the trial period
• Known history of clinically relevant QT prolongation (e.g. long QT syndrome)
• History of severe haemorrhagic or thromboembolic event in the past 6 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis)
• 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 < or = 325mg per day)
• Active alcohol or drug abuse
• Women and men who are sexually active and unwilling to use a medically acceptable method of contraception during the trial
• Pregnancy or breast-feeding
• Patients unable to comply with the protocol
• Uncontrolled hypertension