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Neuropathic Pain in Patients With Cancer
This study is currently recruiting participants.
Verified by DARA Therapeutics, August 2007
Sponsored by: DARA Therapeutics
Information provided by: DARA Therapeutics
ClinicalTrials.gov Identifier: NCT00474916
  Purpose

The purpose of this study is to collect beginning information on whether intravenous (IV) administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients with cancer.


Condition Intervention Phase
Neuropathic Pain
Drug: KRN5500
Phase I
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Krn 5500
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer

Further study details as provided by DARA Therapeutics:

Primary Outcome Measures:
  • Average pain intensity over the previous 24 hours as measured by a numeric rating scale (NRS) ranging from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain." [ Time Frame: Weekly for 10 weeks plus 30 day followup ]
  • Physical Examination, Vital signs and body weight, Electrocardiogram, Laboratory parameters, Adverse events, Clinical Opiate Withdrawal Scale [ Time Frame: Weekly for 10 weeks plus 30 day followup ]

Secondary Outcome Measures:
  • Average pain intensity NRS from daily patient diary , Neuropathic Pain Questionnaire, Brief Pain Inventory, Karnofsky performance status, allodynia, rescue medication, Proportion of patients who achieved a 33% reduction in pain intensity [ Time Frame: Weekly for 10 weeks plus 30 day followup ]

Estimated Enrollment: 18
Study Start Date: June 2006
Estimated Study Completion Date: December 2007
Detailed Description:

Neuropathic pain is a type of pain that results from nerve damage and is characterized by an abnormal hypersensitivity to harmless as well as harmful stimuli. This type of pain is extremely difficult to manage, fails to respond to standard analgesic medications or interventions, and often gets worse instead of better over time. Current approved therapeutic agents often have intolerable side effects and limited efficacy. Thus, there is an urgent need to develop safe and effective drugs to treat neuropathic pain.

Study DTCL100 will be conducted at multiple centers and will enroll patients that have advanced cancer AND neuropathic pain that has not responded well to previous treatment. Eighteen patients will be randomly assigned to receive up to 8 doses of active drug (KRN5500) or placebo. A maximum of 8 doses will be administered weekly over a 10 week period. Patients are encouraged to complete at least 4 treatment visits before a decision is made to complete the full 10 weeks of treatment and the 1 month followup period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Diagnosis of advanced or recurrent cancer
  • No options for curative chemotherapy, but palliative chemotherapy allowed under certain conditions
  • Refractory neuropathic pain rated 4 or greater on 0-10 scale and failure to respond to 2 commonly used treatments
  • If taking opioids for pain, stable regimen over past week before enrolling
  • Karnofsky performance status of 40 or more
  • Females must be sterile or post-menopausal

Exclusion Criteria:

  • Radiation to site of neuropathic pain for past 4 weeks
  • Major surgery within past 2 weeks
  • Liver function and other key labs outside normal parameters
  • ECG showing significant abnormality
  • Myocardial Infarction (heart attack) within past 6 months
  • History of interstitial lung disease
  • History of severe allergic reaction to drugs containing polysorbate 80
  • Other investigational drug within 2 weeks or 5 half-lives (whichever is longer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474916

Contacts
Contact: Linda Jett, MSN 919-861-0232 ljett@darabiosciences.com
Contact: John Didsbury, PhD 919-861-0198 jdidsbury@darabiosciences.com

Locations
United States, California
Cancer Institute Medical Group Recruiting
Los Angeles, California, United States, 90025
Contact: Howard Realubit     310-231-2132     hrealubit@theangelesclinic.org    
Contact: Rebecca Sanchez     310-231-2185     rsanchez@theangelesclinic.org    
Principal Investigator: Tanya Dorff, MD            
University of California / Irvine Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Monica Royale     714-456-6257     arroyo@uci.edu    
Contact: Keri Zabokrtsky     714-456-8214     kzabo@uci.edu    
Principal Investigator: Leonard Sender, MD            
Ghassan Al-Jazayrly, M.D., Inc. Recruiting
Los Angeles, California, United States, 90027
Contact: Jenny Nguyen     213-481-2568        
Principal Investigator: Ghassan Al-Jazayrly, MD            
United States, Florida
Keog Pharma, Inc. Recruiting
Jupiter, Florida, United States, 33477
Contact: Shannan Appel     561-427-3317        
Principal Investigator: Jose Stable, MD            
United States, Louisiana
Hematology and Oncology Specialists, LLC Recruiting
Covington, Louisiana, United States, 70433
Contact: Elizabeth Blakeley     985-892-9090     eblakley@salco.net    
Contact: Mary Ann Ostroske, RN     504-394-0789     mostroske1@salco.net    
Principal Investigator: Jack Saux, MD            
United States, Maryland
St. Agnes Healthcare, Inc Recruiting
Baltimore, Maryland, United States, 21229
Contact: Maryanna Cain     410-368-8622     mcain@stagnes.org    
Contact: Imene Benayache, MD     (410) 368-8623     ibenayac@stagnes.org    
Principal Investigator: Enser Cole, MD            
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Maria Roche, MSN     617-724-4800     mroche@partners.org    
Contact: Audrey Zeh     617-724-4102     azeh1@partners.org    
Principal Investigator: Richard Penson, MD, MRCP            
United States, New Jersey
East Orange VA Medical Center Recruiting
East Orange, New Jersey, United States, 07018
Contact: Barbara Crump, RN     973-395-7090     barbara.crump@va.gov    
Contact: Melanie Gonzalez     9736761000 ext 2199     melanie.gonzalez@va.gov    
Principal Investigator: Victor Chang, MD            
United States, North Carolina
Carolina Pain Institute, PA Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Joan Priddy-Southern, RN     336-765-6181 ext 122     jpsourthern@ccrpain.com    
Principal Investigator: James North, MD            
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Krista Rowe, MSN     919-681-7491     rowe0005@mc.duke.edu    
Contact: Karen Bronson, PhD     9199700577     karen.bronson@duke.edu    
Principal Investigator: Amy Abernethy, MD            
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Kim Segal     801-587-5554     kim.segal@hci.utah.edu    
Contact: Deborah Thorpe, PhD, RN         deborah.thorpe@hci.utah.edu    
Principal Investigator: Sharon Weinstein, MD            
Puerto Rico
Dr. Rivera-Colon Recruiting
Jan Juan, Puerto Rico, 00921
Contact: Agnes Ponce     7872321946     agnesofgod123@hotmail.com    
Contact: Luis Rivera-Colon, MD     7872731946     luismd@coqui.net    
Principal Investigator: Luis Rivera-Colon, MD            
Sponsors and Collaborators
DARA Therapeutics
Investigators
Principal Investigator: Richard Penson, MD, MRCP Massachusetts General Hospital
  More Information

Study ID Numbers: DTCL100
Study First Received: May 15, 2007
Last Updated: August 21, 2007
ClinicalTrials.gov Identifier: NCT00474916  
Health Authority: United States: Food and Drug Administration

Keywords provided by DARA Therapeutics:
Neuropathic pain
Cancer

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on January 16, 2009