Spots Global Cancer Trial Database for Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
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Trial Identification
Brief Title: Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
Official Title: A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma
Study ID: NCT00327600
Conditions
Study Description
Brief Summary: AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.
Detailed Description:
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site 009, Los Angeles, California, United States
Investigational Site 002, Santa Monica, California, United States
University of CO Anschutz Cancer Pavilion, Aurora, Colorado, United States
US Oncology Orlando, Cancer Centers of FL, Ocoee, Florida, United States
US Oncology Albany, New York Oncology, Albany, New York, United States
US Oncology Kettering, Kettering, Ohio, United States
US Oncology Greenville, Cancer Centers of the Carolinas, Greenville, South Carolina, United States
US Oncology, Tyler Cancer Center, Tyler, Texas, United States
Investigational Site 012, Salt Lake City, Utah, United States
US Oncology, Virginia Oncology Assoc, Norfolk, Virginia, United States
US Oncology Spokane, Cancer Care Northwest, Spokane, Washington, United States
Contact Details
Name: Evan Hersh, MD
Affiliation: AmpliMed Corporation
Role: STUDY_DIRECTOR
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