Phase I Study of BI 831266 in Patients With Advanced Solid Tumours

Inclusion criteria

• Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid malignant tumours, who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
• Secure central venous access
• Measurable and/or non-measurable tumour deposits
• Recovery from toxicities of prior anti-cancer therapies at least to CTCAE grade 1
• Age >= 18 years
• Life expectancy >= 3 months
• Written informed consent in accordance with International Conference on Harmonisation guideline for Good Clinical Practice and local legislation
• Eastern Cooperative Oncology Group performance score <= 2

Exclusion criteria

• Serious illness, concomitant non-oncological disease (e.g. active infectious disease), or ongoing toxicity of prior therapies considered by the investigator to potentially compromise patients' safety in this trial
• Pregnancy or breastfeeding
• Symptomatic brain metastases and/or leptomeningeal disease requiring therapy
• Second malignancy requiring therapy
• Left ventricular ejection fraction (LVEF) < 50% in echocardiography
• Clinically significant (i.e. active) cardiovascular disease: CVA/stroke (<= 6 months prior to randomisation), myocardial infarction (<= 6 months prior to randomisation), unstable angina, New York Heart Association Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
• Absolute neutrophil count less than 1500 / mm3
• Platelet count less than 100 000 / mm3
• Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent)
• Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
• Serum creatinine greater than 1.5 mg / dl (> 132 micromol / L, SI unit equivalent)
• Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
• Treatment with other investigational drugs or in another clinical trial within the past two weeks before start of therapy or concomitantly with this trial
• Chemo-, hormone, radio- or immunotherapy within the past two weeks before start of therapy or concomitantly with this trial
• Patients unable to comply with the protocol
• Active alcohol or drug abuse