Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2006-06-30
2009-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KRN5500
KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline
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.
Normal Saline
Placebo consists of IV infusion of normal saline
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
Normal Saline given as dose escalation for placebo
Interventions
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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
Normal Saline given as dose escalation for placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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DARA Therapeutics
INDUSTRY
Responsible Party
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DARA BioSciences and DARA Therapeutics
Principal Investigators
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Richard Penson, MD, MRCP
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Cancer Institute Medical Group
Los Angeles, California, United States
Ghassan Al-Jazayrly, M.D., Inc.
Los Angeles, California, United States
University of California / Irvine Chao Family Comprehensive Cancer Center
Orange, California, United States
Keog Pharma, Inc.
Jupiter, Florida, United States
Hematology and Oncology Specialists, LLC
Covington, Louisiana, United States
St. Agnes Healthcare, Inc
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
East Orange VA Medical Center
East Orange, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolina Pain Institute, PA
Winston-Salem, North Carolina, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Dr. Rivera-Colon
Rio Piedras, , Puerto Rico
Countries
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Other Identifiers
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DTCL100
Identifier Type: -
Identifier Source: org_study_id
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