Clinical trial · Interventional
Neuropathic Pain in Patients With Cancer
A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer
NCT00474916CI-TRIAL-00003799completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuropathic Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KRN5500 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KRN5500
- description
- KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline
- interventionNames
- Drug: KRN5500
- type
- PLACEBO_COMPARATOR
- label
- Normal Saline
- description
- Placebo consists of IV infusion of normal saline
- interventionNames
- Drug: KRN5500
- Drug: Placebo
Primary outcomes (1)
- 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."
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.