Neuropathic Pain in Patients With Cancer

This study has been completed.
Sponsor:
Information provided by:
DARA Therapeutics
ClinicalTrials.gov Identifier:
NCT00474916
First received: May 15, 2007
Last updated: August 13, 2010
Last verified: August 2010
  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
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: June 2006
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474916

Locations
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
Investigators
Principal Investigator: Richard Penson, MD, MRCP Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Linda Jett, MSN, Clinical Director, DARA BioSciences and DARA Therapeutics
ClinicalTrials.gov Identifier: NCT00474916     History of Changes
Other Study ID Numbers: DTCL100
Study First Received: May 15, 2007
Last Updated: August 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by DARA Therapeutics:
Neuropathic pain
Cancer

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

ClinicalTrials.gov processed this record on October 23, 2014