Neuropathic Pain in Patients With Cancer

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: NCT00474916
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : August 16, 2010
Information provided by:
DARA Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Neuropathic Pain Drug: KRN5500 Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer
Study Start Date : June 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: KRN5500
KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline
Drug: KRN5500
Patients are seen weekly and dosed for pain with IV medication of active drug/KRN5500 or placebo . The dose can be escalated, from .6 mg/m2, to 1.2, 1.8, and 2.2 mg/m2.
Placebo Comparator: Normal Saline
Placebo consists of IV infusion of normal saline
Drug: KRN5500
Patients are seen weekly and dosed for pain with IV medication of active drug/KRN5500 or placebo . The dose can be escalated, from .6 mg/m2, to 1.2, 1.8, and 2.2 mg/m2.
Drug: Placebo
Normal Saline given as dose escalation for placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Physical Examination, Vital signs and body weight, Electrocardiogram, Laboratory parameters, Adverse events, Clinical Opiate Withdrawal Scale, rescue medication, Proportion of patients who achieved a 33% reduction in pain intensity [ Time Frame: Weekly for 10 weeks plus 30 day followup ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00474916

United States, California
Cancer Institute Medical Group
Los Angeles, California, United States, 90025
Ghassan Al-Jazayrly, M.D., Inc.
Los Angeles, California, United States, 90027
University of California / Irvine Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
United States, Florida
Keog Pharma, Inc.
Jupiter, Florida, United States, 33477
United States, Louisiana
Hematology and Oncology Specialists, LLC
Covington, Louisiana, United States, 70433
United States, Maryland
St. Agnes Healthcare, Inc
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New Jersey
East Orange VA Medical Center
East Orange, New Jersey, United States, 07018
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Carolina Pain Institute, PA
Winston-Salem, North Carolina, United States, 27103
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Puerto Rico
Dr. Rivera-Colon
Rio Piedras, Puerto Rico, 00921
Sponsors and Collaborators
DARA Therapeutics
Principal Investigator: Richard Penson, MD, MRCP Massachusetts General Hospital

Responsible Party: Linda Jett, MSN, Clinical Director, DARA BioSciences and DARA Therapeutics Identifier: NCT00474916     History of Changes
Other Study ID Numbers: DTCL100
First Posted: May 17, 2007    Key Record Dates
Last Update Posted: August 16, 2010
Last Verified: August 2010

Keywords provided by DARA Therapeutics:
Neuropathic pain

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms