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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neuropathic Pain

Thank you

Trial Information

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


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.


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

Type of Study:

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

Outcome 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."

Outcome Time Frame:

Weekly for 10 weeks plus 30 day followup

Safety Issue:

No

Principal Investigator

Richard Penson, MD, MRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

DTCL100

NCT ID:

NCT00474916

Start Date:

June 2006

Completion Date:

April 2009

Related Keywords:

  • Neuropathic Pain
  • Neuropathic pain
  • Cancer
  • Neuralgia

Name

Location
Huntsman Cancer Institute Salt Lake City, Utah  84112
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Duke University Medical Center Durham, North Carolina  27710
Hematology and Oncology Specialists, LLC New Orleans, Louisiana  70115
Cancer Institute Medical Group Los Angeles, California  90025
East Orange VA Medical Center East Orange, New Jersey  07018
Ghassan Al-Jazayrly, M.D., Inc. Los Angeles, California  90027
University of California / Irvine Chao Family Comprehensive Cancer Center Orange, California  92868
Keog Pharma, Inc. Jupiter, Florida  33477
St. Agnes Healthcare, Inc Baltimore, Maryland  21229
Carolina Pain Institute, PA Winston-Salem, North Carolina  27103