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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Massachusetts General Hospital Pfizer |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00577382 |
The purpose of this study is to evaluate how effective SU011248 works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. SU011248 is a protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work by blocking signals on certain cancer cells which allow the malignant cells to multiply and spread due to a change in the genetic make up of the cancer cell.
Condition | Intervention | Phase |
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Mucosal Melanoma Acral/Lentiginous Melanoma |
Drug: SU011248 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma |
Estimated Enrollment: | 50 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: F. Stephen Hodi, MD | 617-632-5053 | shodi@partners.org |
Contact: Suzanne MacRae, RN | 617-632-5906 | smacrae@partners.org |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: F. Stephen Hodi, MD | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Donald Lawrence, MD | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: David McDermott, MD | |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States | |
Contact: Jeffrey Sosman, MD 800-811-8480 | |
Principal Investigator: Jeffrey Sosman, MD |
Principal Investigator: | F. Stephen Hodi, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( F. Stephen Hodi, MD ) |
Study ID Numbers: | 06-145 |
Study First Received: | December 18, 2007 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00577382 |
Health Authority: | United States: Food and Drug Administration |
Sutent malignant melanoma |
Neuroectodermal Tumors Sunitinib Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |