Neuropathic Pain in Patients With Cancer

DARA Therapeutics

Status and phase: Completed; Phase 2

Conditions: Neuropathic Pain

Treatments: Drug: KRN5500; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00474916

DTCL100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups, including a placebo group

KRN5500

Experimental group

Description:

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

Treatment:

Drug: KRN5500

Normal Saline

Placebo Comparator group

Description:

Placebo consists of IV infusion of normal saline

Treatment:

Drug: KRN5500

Drug: Placebo