Neuropathic Pain in Patients With Cancer
This study has been completed.
Sponsor:
DARA Therapeutics
Information provided by:
DARA Therapeutics
ClinicalTrials.gov Identifier:
NCT00474916
First received: May 15, 2007
Last updated: August 13, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuropathic Pain |
Drug: KRN5500 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer |
Resource links provided by NLM:
Further study details as provided by DARA Therapeutics:
Primary Outcome Measures:
- 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." [ Time Frame: Weekly for 10 weeks plus 30 day followup ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: Weekly for 10 weeks plus 30 day followup ] [ Designated as safety issue: Yes ]
| Enrollment: | 19 |
| Study Start Date: | June 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: KRN5500
KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline
|
Drug: KRN5500
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.
|
|
Placebo Comparator: Normal Saline
Placebo consists of IV infusion of normal saline
|
Drug: KRN5500
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.
Drug: Placebo
Normal Saline given as dose escalation for placebo
|
Detailed Description:
Neuropathic pain is a type of pain that results from nerve damage and is characterized by an abnormal hypersensitivity to harmless as well as harmful stimuli. This type of pain is extremely difficult to manage, fails to respond to standard analgesic medications or interventions, and often gets worse instead of better over time. Current approved therapeutic agents often have intolerable side effects and limited efficacy. Thus, there is an urgent need to develop safe and effective drugs to treat neuropathic pain.
Study DTCL100 will be conducted at multiple centers and will enroll patients that have advanced cancer AND neuropathic pain that has not responded well to previous treatment. Eighteen patients will be randomly assigned to receive up to 8 doses of active drug (KRN5500) or placebo. A maximum of 8 doses will be administered weekly over a 10 week period. Patients are encouraged to complete at least 4 treatment visits before a decision is made to complete the full 10 weeks of treatment and the 1 month followup period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474916
Locations
| United States, California | |
| Cancer Institute Medical Group | |
| Los Angeles, California, United States, 90025 | |
| Ghassan Al-Jazayrly, M.D., Inc. | |
| Los Angeles, California, United States, 90027 | |
| University of California / Irvine Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| United States, Florida | |
| Keog Pharma, Inc. | |
| Jupiter, Florida, United States, 33477 | |
| United States, Louisiana | |
| Hematology and Oncology Specialists, LLC | |
| Covington, Louisiana, United States, 70433 | |
| United States, Maryland | |
| St. Agnes Healthcare, Inc | |
| Baltimore, Maryland, United States, 21229 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New Jersey | |
| East Orange VA Medical Center | |
| East Orange, New Jersey, United States, 07018 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Carolina Pain Institute, PA | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| Puerto Rico | |
| Dr. Rivera-Colon | |
| Rio Piedras, Puerto Rico, 00921 | |
Sponsors and Collaborators
DARA Therapeutics
Investigators
| Principal Investigator: | Richard Penson, MD, MRCP | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Linda Jett, MSN, Clinical Director, DARA BioSciences and DARA Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00474916 History of Changes |
| Other Study ID Numbers: | DTCL100 |
| Study First Received: | May 15, 2007 |
| Last Updated: | August 13, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by DARA Therapeutics:
|
Neuropathic pain Cancer |
Additional relevant MeSH terms:
|
Neuralgia Pain Neurologic Manifestations Nervous System Diseases |
Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013