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Sponsored by: |
Genzyme |
Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00068211 |
This is a Phase II, non-randomized, open label study of ILX651 in patients with inoperable locally advanced or metastatic melanoma. Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate for all patients who are treated with ILX651. The secondary objectives are to determine the progression free survival at 18 weeks, duration of response, time to tumor progression, survival, safety/tolerability of ILX651 and to evaluate the pharmacokinetic profile.
Condition | Intervention | Phase |
Melanoma |
Drug: ILX651 |
Phase II |
MedlinePlus related topics: | Cancer Melanoma |
Drug Information available for: | Tasidotin Tasidotin hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients With Inoperable Locally Advanced or Metastatic Melanoma. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |||||
Arizona Cancer Center at Scottsdale | |||||
Scottsdale, Arizona, United States, 85285 | |||||
Univ of Arizona Cancer Center | |||||
Tucson, Arizona, United States, 85724 | |||||
United States, California | |||||
Cancer Institute Medical Group | |||||
Santa Monica, California, United States, 90404 | |||||
USC / Norris Cancer Center | |||||
Los Angeles, California, United States, 90033 | |||||
United States, Colorado | |||||
Univ of Colorado Cancer Center/ Anschutz Cancer | |||||
Aurora, Colorado, United States, 80010 | |||||
United States, Florida | |||||
US Oncology / Cancer Centers of Florida | |||||
Orlando, Florida, United States, 32806 | |||||
United States, Kansas | |||||
US Oncology / Kansas City Oncology | |||||
Overland Park, Kansas, United States, 66210 | |||||
United States, Massachusetts | |||||
Beth Israel Medical Center | |||||
Boston, Massachusetts, United States, 02215 | |||||
United States, Missouri | |||||
US Oncology / Kansas City Oncology and Hematology | |||||
Kansas City, Missouri, United States, 64111 | |||||
Center for Cancer Care Research | |||||
St. Louis, Missouri, United States, 63141 | |||||
United States, New York | |||||
US Oncology / Albany Regional Cancer Center | |||||
Albany, New York, United States, 12208 | |||||
United States, Ohio | |||||
US Oncology / Dayton Oncology and Hematology | |||||
Kettering, Ohio, United States, 45409 | |||||
United States, South Carolina | |||||
US Oncology / Cancer Centers of the Carolinas | |||||
Greenville, South Carolina, United States, 29615 | |||||
United States, Texas | |||||
St. Luke's Episcopal Hospital | |||||
Houston, Texas, United States, 77030 | |||||
US Oncology / Mary Crowley Medical Research | |||||
Dallas, Texas, United States, 75246 | |||||
US Oncology/ Tyler Cancer Center | |||||
Tyler, Texas, United States, 75702 | |||||
US Oncology /Texas Oncology | |||||
Ft. Worth, Texas, United States, 76104 | |||||
United States, Washington | |||||
Seattle Cancer Care Alliance | |||||
Seattle, Washington, United States, 98109 | |||||
US Oncology / Cancer Care Northwest | |||||
Spokane, Washington, United States, 99218 |
Genzyme |
Study ID Numbers: | ILX651-211 |
First Received: | September 9, 2003 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00068211 |
Health Authority: | United States: Food and Drug Administration |
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