KX2-391 in Treating Patients With Advanced Solid Tumors o... | NCT00646139 | Trialant
NCT00646139
Sponsor
Roswell Park Cancer Institute
Status
Completed
Last Update Posted
Mar 2, 2011Estimated
Enrollment
7Actual
Phase
Phase 1
Conditions
Lymphoma
Lymphoproliferative Disorder
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Src kinase inhibitor KX2-391
immunoenzyme technique
pharmacological study
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00646139
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000589972
Secondary IDs
ID
Type
Description
Link
RPCI-I-112607
KINEX-KX01-01-07
Brief Title
KX2-391 in Treating Patients With Advanced Solid Tumors or Lymphoma That Did Not Respond to 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
Acronym
Not provided
Organization
Roswell Park Cancer InstituteOTHER
Status Module
Record Verification Date
Mar 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2007
Primary Completion Date
Aug 2008Actual
Completion Date
Mar 2009Actual
First Submitted Date
Mar 27, 2008
First Submission Date that Met QC Criteria
Mar 27, 2008
First Posted Date
Mar 28, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 1, 2011
Last Update Posted Date
Mar 2, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Roswell Park Cancer InstituteOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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 Module
Conditions
Lymphoma
Lymphoproliferative Disorder
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific
recurrent adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
adult grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
splenic marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
7Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Src kinase inhibitor KX2-391
Drug
immunoenzyme technique
Other
pharmacological study
Other
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum tolerated dose
Secondary Outcomes
Measure
Description
Time Frame
Safety
Pharmacokinetics
Biological effects
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Confirmed diagnosis of advanced solid tumor or lymphoma
Metastatic or unresectable disease
Standard curative or palliative measures do not exist or are no longer effective
Patients with treated brain or ocular metastases are eligible
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)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Alex A. Adjei, MD, PhD
Roswell Park Cancer Institute
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Roswell Park Cancer Institute
Buffalo
New York
14263-0001
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage III mycosis fungoides/Sezary syndrome
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage IV mycosis fungoides/Sezary syndrome
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult grade III lymphomatoid granulomatosis
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
intraocular lymphoma
primary central nervous system non-Hodgkin lymphoma