Lymphoma Clinical Trial
Official title:
A Combined Rising Single-Dose (RSD) and Rising Multiple-Dose (RMD) Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of KX2-391 in Patients With Advanced Malignancies That Are Refractory to Conventional Therapies
RATIONALE: KX2-391 may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of KX2-391 in
treating patients with advanced solid tumors or lymphoma that did not respond to treatment.
OBJECTIVES:
Primary
- To define the maximum tolerated dose of KX2-391 when administered as multiple oral
solutions in patients with refractory advanced solid tumors and lymphoma.
Secondary
- To determine the safety and tolerability of KX2-391 given as single and multiple oral
solutions in these patients.
- To characterize the pharmacokinetic profile of single dosing and multiple dosing of
KX2-391 in these patients.
- To determine the biological effects of KX2-391.
OUTLINE: This is a multicenter study.
Patients receive oral KX2-391 once or twice daily for 3 weeks. Treatment repeats every 4
weeks in the absence of disease progression or unacceptable toxicity.
Blood and urine samples are collected periodically for pharmacokinetic studies. Biological
effects are assessed by measuring plasma levels of vascular endothelial growth factor by
ELISA. Levels of phospho-Src Tyr and transphosphorylation of selected substrates are
measured in peripheral blood mononuclear cells.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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