Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of TL32711 In Combination With Gemcitabine in Patients With Advanced Solid Tumors
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
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. ;
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