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Evaluation of KX2-391 in Patients With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658970
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : June 8, 2011
Information provided by:
Athenex, Inc.

Tracking Information
First Submitted Date  ICMJE January 15, 2008
First Posted Date  ICMJE April 16, 2008
Last Update Posted Date June 8, 2011
Study Start Date  ICMJE November 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
Determine maximum tolerated dose of the drug [ Time Frame: 64 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00658970 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
Pharmacokinetics, Pharmacodynamics, Efficacy [ Time Frame: 64 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Evaluation of KX2-391 in Patients With Advanced Malignancies
Official Title  ICMJE 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
Brief Summary The purpose of this Phase 1 study is to determine the safety and tolerability of KX2-391 in cancer patients.
Detailed Description The purpose of this first in human study is to determine the safety and pharmacokinetics of KX2-391 in patients with solid tumors and lymphoma, who are refractory to conventional cancer treatments. In addition, pharmacodynamics will be evaluated using biomarkers in peripheral blood mononuclear cells and in tissue biopsy samples.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • Lymphoma
Intervention  ICMJE Drug: KX2-391
2 mg (starting dose)rising dose, oral dosing, twice daily, 21 day cycle(s); until progression or unacceptable toxicity develops
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 10, 2008)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed written informed consent
  • Adults over age 18 years of age
  • Confirmed advanced solid tumor or lymphoma that may be metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with treated brain or ocular metastases are also eligible
  • ECOG performance status of 0-2
  • Life expectancy of at least 14 weeks
  • Adequate bone marrow reserve
  • Adequate liver function as demonstrated by serum bilirubin, alanine aminotransferase (ALT), aspartate transaminase (AST) and alkaline phosphatase (ALP)
  • Adequate renal function (serum creatinine </= 1.5 x ULN or calculated creatinine clearance > 60 ml/min)
  • Normal coagulation profile (PT/INR and aPTT within institutional normal limits) for those who give consent to tumor biopsy, within 1 week prior to the procedure.
  • Negative pregnancy test for females at Screening, preferably done within 1 week before Day 1 of dosing (not applicable to patients with bilateral oophorectomy and/or hysterectomy)
  • Willing to abstain from sexual activity or practice physical barrier contraception 28 days before Day 1 of dosing and 6 months after the last dose for the patient
  • Signed written informed consent for tumor biopsy for the additional 10 subjects that will be dosed at the MTD and who have accessible tumors

Exclusion Criteria:

  • Unresolved toxicity of higher than Grade 1 severity from previous anti-cancer treatment or investigational agents
  • Receiving or having received investigational agents or systemic anti-cancer agents within 14 days of Day 1 of dosing or 28 days for those agents with unknown elimination half-lives or half-lives of greater than 50 hours
  • Received extensive radiation therapy including sternum, pelvis, scapulae, vertebrae or skull, </= 4 weeks or low dose palliative radiation therapy limited to limbs </= 1 week prior to starting study drug, or who have not recovered from side effects of such therapy
  • Currently taking hormones (i.e., estrogen contraceptives, hormone replacement, anti-estrogen), anti-platelet agents or anti-coagulants, e.g. coumadin, except for those who are on prophylactic doses of anti-coagulants for indwelling venous catheters
  • Use of strong inhibitors or inducers of cytochrome P450 3A4 enzymes 2 weeks or 5 half-lives prior to Day 1 of dosing and during the study (refer to Appendix 3)
  • Pregnant or breast-feeding
  • Major surgery within 4 weeks prior to Day 1 of dosing
  • Major surgery to the upper gastrointestinal tract, or inflammatory bowel disease, malabsorption syndrome or other medical condition that may interfere with oral absorption
  • Signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions which, in the opinion of the investigator, makes it undesirable for the subject to participate in the study or which could jeopardize compliance with the protocol
  • History of angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack or cardiac arrhythmia requiring medical therapy
  • Evidence of hepatitis B or C, human immunodeficiency (HIV) infection, coagulation disorders, or hemolytic conditions, e.g. sickle cell anemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00658970
Other Study ID Numbers  ICMJE KX01-01-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allen Barnett/Chief Executivew Officer, Kinex Pharmaceuticals
Study Sponsor  ICMJE Athenex, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aung Naing, M.D. M.D. Anderson Cancer Center
Principal Investigator: Roger B Cohen, M.D. Fox Chase Cancer Center
PRS Account Athenex, Inc.
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP