NP2 Enkephalin For Treatment of Intractable Cancer Pain

Phase 2

Completed

• Conditions: Intractable Pain; Neoplasms
• Interventions: Biological: Placebo; Biological: NP2

• Registration Number: NCT01291901
• Lead Sponsor: Diamyd Inc

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.

Detailed Description

Chronic severe pain remains a significant unmet medical need in patients that have progressive cancer. Existing treatments have limited efficacy and also suffer significant side effects. This is a multi-center, randomized, double blind, placebo-controlled clinical trial designed to evaluate the impact of intradermal injection of NP2 in subjects who have intractable pain due to malignant disease. NP2 is a gene transfer vector engineered to express human preproenkephalin, a gene naturally involved in pain control. Delivery of NP2 directly to the site of pain caused by cancer is intended to provide increased Enkephalin peptides, which bind to opioid receptors, that may allow better pain control.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-04
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-09
• Primary Completion: 2012-07
• Study Completion: 2013-11
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-28
• Disposition First Submitted QC: 2014-07-28
• Last Update Submitted: 2014-07-28
• Disposition First Posted: 2014-08-08
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Histologically confirmed malignant disease.
• Intractable pain related to malignancy.
• Females must be postmenopausal or practicing birth control.
• Able to provide appropriate written consent.

Main

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single 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.
Active NP2	NP2	Single 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.

Primary Outcome Measures

Name	Time	Method
Pain Measured by the Numerical Rating Scale (NRS)	Days -5 to -1 predosing and days 3 to 14 postdosing	• Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.

Secondary Outcome Measures

Name	Time	Method
Opioid Pain Medication Usage Morphine Equivalent Units (MEU)	Days -5 to -1 predosing and 3 to 14 postdosing	•Change from baseline of use of opioid pain medication average daily MEU of Placebo compared to Active NP2 cohorts
Quality of Life ECOG	Baseline and Week 1, 2 and 4	•Quality of Life measured by Eastern Cooperative Oncology Group Performance Status (ECOG) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts.
Quality of Life SF-12	Baseline and Week 1, 2 and 4	•Quality of Life measured by the 12-Item Short Form Health Survey (SF-12v2) at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts.
Pain SF-MPQ	Baseline and Week 1, 2 and 4	•Short Form McGill Pain Questionnaire (SF-MPQ-2) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts

Trial Locations

Locations (18)

Arizona Clinical Research Center; 🇺🇸 Tucson, Arizona, United States

Compassionate Cancer Care Medical Group, Inc.; 🇺🇸 Corona, California, United States

Hematology Oncology Associates; 🇺🇸 Oakland, California, United States

Cancer Care Associates; 🇺🇸 Fresno, California, United States

White Memorial Medical Center; 🇺🇸 Los Angeles, California, United States

TriWest Research Associates; 🇺🇸 La Mesa, California, United States

Medical Oncology Associates; 🇺🇸 Spokane, Washington, United States

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Medical Therapy and Research; 🇺🇸 San Antonio, Texas, United States

Advanced Pharma CR; 🇺🇸 Miami, Florida, United States

Center for Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Signal Point Clinical research Center; 🇺🇸 Middletown, Ohio, United States

Hematology Oncology Associatesof Rhode Island; 🇺🇸 Cranston, Rhode Island, United States

Montana Cancer Institute Foundation; 🇺🇸 Missoula, Montana, United States

Christie Clinic; 🇺🇸 Champaign, Illinois, United States

Pain Research of Oregon; 🇺🇸 Eugene, Oregon, United States

Global Scientific Innovations; 🇺🇸 Evansville, Indiana, United States

Better Health Clinical Research Inc; 🇺🇸 Newnan, Georgia, United States