PRIMARY OBJECTIVES:~I. To determine the maximum tolerated dose (MTD) and recommended Phase II dose of TL32711 (smac mimetic TL32711) in combination with gemcitabine (gemcitabine hydrochloride) in patients with advanced solid tumors.~SECONDARY OBJECTIVES:~I. To determine the toxicity and safety profile of TL32711 in combination with gemcitabine in patients with advanced solid tumors.~II. To determine the pharmacokinetic profile of TL32711 and gemcitabine when administered in combination.~III. To determine the preliminary efficacy of the study combination in patients with advanced solid tumors.~IV. To determine the relationship between predictive biomarkers and clinical activity using archival tumor tissue samples for biomarker analysis.~OUTLINE: This is a dose-escalation study of smac mimetic TL32711.~Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes and smac mimetic TL32711 IV over 30 minutes once weekly for 2 weeks. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~After completion of study treatment, patients are followed up for at least 4 weeks.
The purpose of this study is to determine the dose of smac mimetic TL32711 that is safe and tolerated when given with gemcitabine hydrochloride to patients with advanced cancer