Clinical trial NCT00474916: Neuropathic Pain in Patients With Cancer
Official title: A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: Neuropathic pain
Cancer
Lead sponsor: DARA Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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."
timeFrame: Weekly for 10 weeks plus 30 day followup
Secondary outcomes:
measure: 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
timeFrame: Weekly for 10 weeks plus 30 day followup
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cancer Institute Medical Group
state: California
city: Los Angeles
country: United States
facility: Ghassan Al-Jazayrly, M.D., Inc.
state: California
city: Orange
country: United States
facility: University of California / Irvine Chao Family Comprehensive Cancer Center
state: California
city: Jupiter
country: United States
facility: Keog Pharma, Inc.
state: Florida
city: Covington
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: Baltimore
country: United States
facility: St. Agnes Healthcare, Inc
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: East Orange
country: United States
facility: East Orange VA Medical Center
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Carolina Pain Institute, PA
state: North Carolina
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Rio Piedras
country: Puerto Rico
facility: Dr. Rivera-Colon
Study officials:
affiliation: Massachusetts General Hospital
name: Richard Penson, MD, MRCP
role: PRINCIPAL_INVESTIGATOR
References: