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
- To define the maximum tolerated dose of KX2-391 when administered as multiple oral
solutions in patients with refractory advanced solid tumors and lymphoma.
- 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
Maximum tolerated dose
Alex A. Adjei, MD, PhD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|