HIV Infection Clinical Trial
Official title:
Phase I Trial of Cabozantinib (XL184) for Advanced Solid Tumors in Persons With HIV Infection
This phase I trial studies the side effects and best dose of cabozantinib s-malate in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment and human immunodeficiency virus. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To determine the safety and tolerability of cabozantinib (XL184) (cabozantinib s-malate) as a single agent in solid tumor participants with human immunodeficiency virus (HIV) infection and to determine the maximal tolerated dose (MTD) in this patient population. SECONDARY OBJECTIVES: I. To investigate possible pharmacokinetic interactions between cabozantinib and antiretroviral therapy in persons with HIV infection. II. To investigate the effects of therapy on participant immune status and HIV viral load. III. To preliminarily assess objective response rates associated with treatment for commonly represented tumors. OUTLINE: This is a dose-escalation study. Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days. ;
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