KX2-391 in Treating Patients With Advanced Solid Tumors or Lymphoma That Did Not Respond to Treatment
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.
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: Src kinase inhibitor KX2-391
Other: immunoenzyme technique
Other: pharmacological study
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Safety [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Designated as safety issue: No ]
- Biological effects [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||March 2009|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
- 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.
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Alex A. Adjei, MD, PhD||Roswell Park Cancer Institute|