Neuropathic Pain in Patients With Cancer

Neuropathic Pain Clinical Trial

Official title:

A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474916
• Other study ID #: DTCL100
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2007
• Last updated: August 13, 2010
• Start date: June 2006
• Est. completion date: April 2009

Study information

• Verified date: August 2010
• Source: DARA Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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
Normal Saline given as dose escalation for placebo

Locations

Country	Name	City	State
Puerto Rico	Dr. Rivera-Colon	Rio Piedras
United States	St. Agnes Healthcare, Inc	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Hematology and Oncology Specialists, LLC	Covington	Louisiana
United States	Duke University Medical Center	Durham	North Carolina
United States	East Orange VA Medical Center	East Orange	New Jersey
United States	Keog Pharma, Inc.	Jupiter	Florida
United States	Cancer Institute Medical Group	Los Angeles	California
United States	Ghassan Al-Jazayrly, M.D., Inc.	Los Angeles	California
United States	University of California / Irvine Chao Family Comprehensive Cancer Center	Orange	California
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Carolina Pain Institute, PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
DARA Therapeutics

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."		Weekly for 10 weeks plus 30 day followup
Secondary	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		Weekly for 10 weeks plus 30 day followup