BI 2536 in Treating Patients With Recurrent or Metastatic Solid Tumors

OBJECTIVES: * Investigate if BI 2536 demonstrates antitumor activity in the selected tumor types. * Further document its safety profile in the treated patient population. * Describe the plasma concentration time-course following administration of a single administration of BI 2536 in patients with different tumor types using an appropriate population pharmacokinetic model. OUTLINE: This is a multicenter study. Patients receive BI 2536 IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Blood is collected periodically during study. Plasma samples are analyzed for pharmacokinetic studies by HPLC and tandem mass spectrometry. After completion of study treatment, patients are followed every 3 months.