KX2-391 in Treating Patients With Advanced Solid Tumors or Lymphoma That Did Not Respond to Treatment

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Lymphoproliferative Disorder; Small Intestine Cancer; Lymphoma

• Registration Number: NCT00646139
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Primary Completion: 2008-08
• Study Completion: 2009-03
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-01
• Last Update Posted: 2011-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose

Secondary Outcome Measures

Name	Time	Method
Safety
Pharmacokinetics
Biological effects

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States