Finding studies
Finding studies
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Lead
Roswell Park Cancer Institute
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted