NCT00474916

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2006

Typical duration for phase_2

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 16, 2010

Status Verified

August 1, 2010

Enrollment Period

2.8 years

First QC Date

May 15, 2007

Last Update Submit

August 13, 2010

Conditions

Neuropathic Pain

Keywords

Neuropathic painCancer

Outcome Measures

Primary Outcomes (1)

  • 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."

    Weekly for 10 weeks plus 30 day followup

Secondary Outcomes (1)

  • Physical Examination, Vital signs and body weight, Electrocardiogram, Laboratory parameters, Adverse events, Clinical Opiate Withdrawal Scale, rescue medication, Proportion of patients who achieved a 33% reduction in pain intensity

    Weekly for 10 weeks plus 30 day followup

Study Arms (2)

KRN5500

EXPERIMENTAL

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

Drug: KRN5500

Normal Saline

PLACEBO COMPARATOR

Placebo consists of IV infusion of normal saline

Drug: KRN5500Drug: Placebo

Interventions

KRN5500DRUG

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.

KRN5500Normal Saline
PlaceboDRUG

Normal Saline given as dose escalation for placebo

Normal Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Cancer Institute Medical Group

Los Angeles, California, 90025, United States

Location

Ghassan Al-Jazayrly, M.D., Inc.

Los Angeles, California, 90027, United States

Location

University of California / Irvine Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Keog Pharma, Inc.

Jupiter, Florida, 33477, United States

Location

Hematology and Oncology Specialists, LLC

Covington, Louisiana, 70433, United States

Location

St. Agnes Healthcare, Inc

Baltimore, Maryland, 21229, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

East Orange VA Medical Center

East Orange, New Jersey, 07018, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Carolina Pain Institute, PA

Winston-Salem, North Carolina, 27103, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Dr. Rivera-Colon

Rio Piedras, 00921, Puerto Rico

Location

MeSH Terms

Conditions

NeuralgiaNeoplasms

Interventions

KRN 5500

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Penson, MD, MRCP

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 17, 2007

Study Start

June 1, 2006

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

August 16, 2010

Record last verified: 2010-08

Locations

US(11)PR(1)