Trial | NCT00474916  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    krn 5500 ...

  • Study Participants

    19
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.
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 Started
Jun 30
2006
Primary Completion
Mar 31
2009
Study Completion
Apr 30
2009
Last Update
Aug 16
2010
Estimate

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

KRN5500 Experimental

KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline

Normal Saline Placebo Comparator

Placebo consists of IV infusion of normal saline

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
No Results Posted