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Sponsored by: |
DARA Therapeutics |
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Information provided by: | DARA Therapeutics |
ClinicalTrials.gov Identifier: | NCT00474916 |
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 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer |
Estimated Enrollment: | 18 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda Jett, MSN | 919-861-0232 | ljett@darabiosciences.com |
Contact: John Didsbury, PhD | 919-861-0198 | jdidsbury@darabiosciences.com |
United States, California | |
Cancer Institute Medical Group | Recruiting |
Los Angeles, California, United States, 90025 | |
Contact: Howard Realubit 310-231-2132 hrealubit@theangelesclinic.org | |
Contact: Rebecca Sanchez 310-231-2185 rsanchez@theangelesclinic.org | |
Principal Investigator: Tanya Dorff, MD | |
University of California / Irvine Chao Family Comprehensive Cancer Center | Recruiting |
Orange, California, United States, 92868 | |
Contact: Monica Royale 714-456-6257 arroyo@uci.edu | |
Contact: Keri Zabokrtsky 714-456-8214 kzabo@uci.edu | |
Principal Investigator: Leonard Sender, MD | |
Ghassan Al-Jazayrly, M.D., Inc. | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Jenny Nguyen 213-481-2568 | |
Principal Investigator: Ghassan Al-Jazayrly, MD | |
United States, Florida | |
Keog Pharma, Inc. | Recruiting |
Jupiter, Florida, United States, 33477 | |
Contact: Shannan Appel 561-427-3317 | |
Principal Investigator: Jose Stable, MD | |
United States, Louisiana | |
Hematology and Oncology Specialists, LLC | Recruiting |
Covington, Louisiana, United States, 70433 | |
Contact: Elizabeth Blakeley 985-892-9090 eblakley@salco.net | |
Contact: Mary Ann Ostroske, RN 504-394-0789 mostroske1@salco.net | |
Principal Investigator: Jack Saux, MD | |
United States, Maryland | |
St. Agnes Healthcare, Inc | Recruiting |
Baltimore, Maryland, United States, 21229 | |
Contact: Maryanna Cain 410-368-8622 mcain@stagnes.org | |
Contact: Imene Benayache, MD (410) 368-8623 ibenayac@stagnes.org | |
Principal Investigator: Enser Cole, MD | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Maria Roche, MSN 617-724-4800 mroche@partners.org | |
Contact: Audrey Zeh 617-724-4102 azeh1@partners.org | |
Principal Investigator: Richard Penson, MD, MRCP | |
United States, New Jersey | |
East Orange VA Medical Center | Recruiting |
East Orange, New Jersey, United States, 07018 | |
Contact: Barbara Crump, RN 973-395-7090 barbara.crump@va.gov | |
Contact: Melanie Gonzalez 9736761000 ext 2199 melanie.gonzalez@va.gov | |
Principal Investigator: Victor Chang, MD | |
United States, North Carolina | |
Carolina Pain Institute, PA | Recruiting |
Winston-Salem, North Carolina, United States, 27103 | |
Contact: Joan Priddy-Southern, RN 336-765-6181 ext 122 jpsourthern@ccrpain.com | |
Principal Investigator: James North, MD | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Krista Rowe, MSN 919-681-7491 rowe0005@mc.duke.edu | |
Contact: Karen Bronson, PhD 9199700577 karen.bronson@duke.edu | |
Principal Investigator: Amy Abernethy, MD | |
United States, Utah | |
Huntsman Cancer Institute | Recruiting |
Salt Lake City, Utah, United States, 84112 | |
Contact: Kim Segal 801-587-5554 kim.segal@hci.utah.edu | |
Contact: Deborah Thorpe, PhD, RN deborah.thorpe@hci.utah.edu | |
Principal Investigator: Sharon Weinstein, MD | |
Puerto Rico | |
Dr. Rivera-Colon | Recruiting |
Jan Juan, Puerto Rico, 00921 | |
Contact: Agnes Ponce 7872321946 agnesofgod123@hotmail.com | |
Contact: Luis Rivera-Colon, MD 7872731946 luismd@coqui.net | |
Principal Investigator: Luis Rivera-Colon, MD |
Principal Investigator: | Richard Penson, MD, MRCP | Massachusetts General Hospital |
Study ID Numbers: | DTCL100 |
Study First Received: | May 15, 2007 |
Last Updated: | August 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00474916 |
Health Authority: | United States: Food and Drug Administration |
Neuropathic pain Cancer |
Pain |