TAK-659 and Paclitaxel in Treating Patients With Advanced Solid Tumors

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Description

PRIMARY OBJECTIVES I. To define the maximum tolerated doses (MTD) of spleen tyrosine kinase inhibitor TAK-659 (TAK-659) and paclitaxel. II. To define the safety profiles of the combination. SECONDARY OBJECTIVES I. To evaluate clinical response signals to the combination. II. To analyze pharmacokinet...

PRIMARY OBJECTIVES I. To define the maximum tolerated doses (MTD) of spleen tyrosine kinase inhibitor TAK-659 (TAK-659) and paclitaxel. II. To define the safety profiles of the combination. SECONDARY OBJECTIVES I. To evaluate clinical response signals to the combination. II. To analyze pharmacokinetic interactions between TAK-659 and paclitaxel. III. To assess predictive biomarkers (baseline molecular mutation status) and/or resistant pathways by comparing molecular signatures at baseline versus at time of relapse in patients who have achieved objective responses. OUTLINE: This is a dose-escalation study of spleen tyrosine kinase inhibitor TAK-659 and paclitaxel. Patients receive spleen tyrosine kinase inhibitor TAK-659 orally (PO) once daily (QD) and paclitaxel intravenously (IV) over approximately 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28 days.

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