A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related Pain

This is a randomized (study drug assigned by chance), double-blind (neither the physician
nor the patient knows the name of the assigned drug) study to evaluate the safety and
effectiveness of JNJ-42160443 compared with placebo in the treatment of men and women 18
years of age or older who are terminally ill (ie, patients who are in or who are candidates
for hospice or palliative [other medical care] care for end-of-life management) with
moderate to severe, chronic, cancer-related pain that is not controlled by standard pain
medications and who have a diagnosis of active cancer. The duration of the study will be
approximately 62 weeks (includes screening, the 4-week double-blind phase followed by the
48-week open-label [study doctor and patient knows the name of the assigned treatment]
extension phase and a posttreatment phase). A single dose of JNJ-42160443 or matching
placebo given as an (subcutaneous [SC]) injection under the skin during the double-blind
treatment period. During the open-label period, JNJ-42160443 will be given once every 4
weeks for up to 48 weeks.

Inclusion Criteria:

- Terminally ill cancer patients as per judgment of the investigator (eg, patients who
are in or who are candidates for hospice or palliative care for end-of-life
management); Diagnosis of moderate to severe pain directly related to an active
cancer that is not controlled by standard pain treatments.

Exclusion Criteria:Planned major surgical procedures during the double-blind treatment
phase that may affect study outcomes; Prior treatment with any other investigational NGF
inhibitor therapy; Known allergies, hypersensitivity, or intolerance to JNJ-42160443 or
its excipients; Enrolled in any investigational study within the previous 4 weeks or 5
half-lives of the investigational drug (whichever is longer), or are currently enrolled in
another investigational study at the time of screening