NP2 Enkephalin For Treatment of Intractable Cancer Pain
A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy
1 other identifier
interventional
33
1 country
18
Brief Summary
The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2011
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 4, 2011
CompletedFirst Posted
Study publicly available on registry
February 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedAugust 8, 2014
July 1, 2014
1.5 years
February 4, 2011
July 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Measured by the Numerical Rating Scale (NRS)
• Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.
Days -5 to -1 predosing and days 3 to 14 postdosing
Secondary Outcomes (4)
Opioid Pain Medication Usage Morphine Equivalent Units (MEU)
Days -5 to -1 predosing and 3 to 14 postdosing
Quality of Life ECOG
Baseline and Week 1, 2 and 4
Quality of Life SF-12
Baseline and Week 1, 2 and 4
Pain SF-MPQ
Baseline and Week 1, 2 and 4
Study Arms (2)
Active NP2
EXPERIMENTALSingle intradermal dose of active NP2. An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.
Placebo
PLACEBO COMPARATORSingle intradermal dose of placebo (vehicle). An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.
Interventions
NP2 is a replication defective HSV-1 based gene transfer vector engineered to express human preproenkephalin. The drug will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.
The placebo (vehicle) will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.
Eligibility Criteria
You may qualify if:
- Histologically confirmed malignant disease.
- Intractable pain related to malignancy.
- Females must be postmenopausal or practicing birth control.
- Able to provide appropriate written consent.
You may not qualify if:
- Positive pregnancy test prior to receiving study treatment.
- Serious uncontrolled medical condition other than malignancy (e.g. congestive heart failure, coagulopathy, uncontrolled diabetes).
- Evidence of active Hepatitis B, Hepatitis C, or HIV infection.
- Evidence of viral, bacterial, or fungal infection in the planned treatment area.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diamyd Inclead
- Paragon Biomedicalcollaborator
- invivodata, Inc.collaborator
Study Sites (18)
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Arizona Clinical Research Center
Tucson, Arizona, 85715, United States
Compassionate Cancer Care Medical Group, Inc.
Corona, California, 92879, United States
Cancer Care Associates
Fresno, California, 93720, United States
TriWest Research Associates
La Mesa, California, 91942, United States
White Memorial Medical Center
Los Angeles, California, 90033, United States
Hematology Oncology Associates
Oakland, California, 94609, United States
Advanced Pharma CR
Miami, Florida, 33175, United States
Better Health Clinical Research Inc
Newnan, Georgia, 30265, United States
Christie Clinic
Champaign, Illinois, 61820, United States
Global Scientific Innovations
Evansville, Indiana, 47714, United States
Montana Cancer Institute Foundation
Missoula, Montana, 59802, United States
Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Signal Point Clinical research Center
Middletown, Ohio, 45042, United States
Pain Research of Oregon
Eugene, Oregon, 97401, United States
Hematology Oncology Associatesof Rhode Island
Cranston, Rhode Island, 02920, United States
Medical Therapy and Research
San Antonio, Texas, 78217, United States
Medical Oncology Associates
Spokane, Washington, 99208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Darren Wolfe, Ph.D.
Diamyd Inc
- PRINCIPAL INVESTIGATOR
David Fink, M.D.
University of Michigan
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2011
First Posted
February 9, 2011
Study Start
January 1, 2011
Primary Completion
July 1, 2012
Study Completion
November 1, 2013
Last Updated
August 8, 2014
Record last verified: 2014-07