An Open Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 811283 Administered Intravenously Over 24 h Continuous Infusion in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
Inclusion Criteria
Inclusion criteria:
Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid
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 Evaluable tumour deposits Recovery from reversible toxicities of prior anti-cancer
therapies Age >= 18 years Life expectancy >= 6 months Written informed consent in
accordance with International Conference on Harmonisation (ICH) guideline for Good
Clinical Practice (GCP) 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 Known brain
metastases Second malignancy requiring therapy Left ventricular ejection fraction (LVEF) <
50% in echocardiography or clinical congestive heart failure New York Heart Association
grade III - IV Myocardial infarction within the last 6 months prior to inclusion or
symptomatic coronary artery disease Absolute neutrophil count less than 1500 / mm3
Platelet count less than 100 000 / mm3 Bilirubin greater than 1.5 mg / dl (> 26 mcmol / 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 mcmol / 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