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Clinical Trial Summary

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.


Clinical Trial Description

- Participants will be given a bottle of SU011248 pills and will be asked to take pills once daily for 28 days on an ongoing basis. Participants will return every 28 days for new pills.

- During all treatment cycles, participants will have a physical exam and undergo blood tests at every visit.

- After a month of receiving the study drug participants will undergo a repeat PET scan to see if the drug has caused any early changes to their cancer.

- At week 8 a repeat chest, abdomen and pelvic CT will be performed.

- Participants will be on this research study for approximately one year. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00577382
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 2007
Completion date July 2016

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01120275 - Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma Phase 2
Completed NCT00243061 - AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma Phase 2
Completed NCT01395121 - A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread Phase 2
Completed NCT00470470 - Imatinib Mesylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery Phase 2