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

NCT ID: NCT00646139

Last Updated: 2011-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-03-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Src kinase inhibitor KX2-391

Intervention Type: DRUG

immunoenzyme technique

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy ≥ 14 weeks
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL
• Serum bilirubin ≤ 2.5 times upper limit of normal (ULN)
• ALT and AST ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Serum creatinine ≤ 1.5 times ULN or creatinine clearance > 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception for 1 month prior to, during, and for 6 months after completion of study treatment
• No inflammatory bowel disease, malabsorption syndrome, or other medical condition that may interfere with oral drug absorption
• No signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions including, but not limited to, active infections that, in the opinion of the investigator, precludes protocol participation or compliance
• No history of any of the following within the past 6 months:

• Angina pectoris
• Coronary artery disease
• Hypertension
• Cerebral vascular accident
• Transient ischemic attack uncontrolled by medical therapy
• No history of confirmed cardiac conduction abnormalities or arrhythmias
• No known history of hepatitis B or C, or HIV infection
• No known history of coagulation disorders or hemolytic conditions (e.g., sickle cell anemia)

PRIOR CONCURRENT THERAPY:

• Recovered from all prior therapy
• No prior major surgery to the upper gastrointestinal tract
• More than 2 weeks since prior investigational agents or systemic anticancer agents (28 days for agents with unknown elimination half-lives or known elimination half-lives > 50 hours)
• More than 4 weeks since prior radiotherapy to the sternum, pelvis, scapulae, vertebrae, or skull and recovered
• More than 4 weeks since prior major surgery
• More than 1 week since prior palliative low-dose radiotherapy to the limbs and recovered
• More than 2 weeks since prior and no concurrent hormones (e.g., estrogen contraceptives, hormone replacement, anti-estrogen, or progesterone) or antiplatelet agents
• More than 2 weeks since prior and no concurrent anticoagulants (e.g., coumadin) except prophylactic doses of anticoagulants for indwelling venous catheters
• More than 2 weeks or 5 half-lives since prior and no concurrent cytochrome P450 modulators (e.g., strong inducers or inhibitors)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Roswell Park Cancer Institute

Principal Investigators

Alex A. Adjei, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-I-112607

Identifier Type: -

Identifier Source: secondary_id

KINEX-KX01-01-07

Identifier Type: -

Identifier Source: secondary_id

CDR0000589972

Identifier Type: -

Identifier Source: org_study_id