A phase II trial of MGCD516, a multi-receptor tyrosine kinase inhibitor, in advanced liposarcoma and other soft tissue sarcomas

The purpose of this study is to evaluate the effectiveness of a new medication, MGCD516, for the treatment of soft tissue and bone sarcomas. MGCD516 is an oral drug which blocks certain proteins on cancer cells called receptor tyrosine kinases. Receptor tyrosine kinases are proteins that help transmit signals into cells that cause the cells to grow and divide. In sarcoma, and many other cancers, these proteins become overactive and cause the cancer cells to grow and divide more quickly than normal cells and to behave more aggressively than normal cells. MGCD516 blocks these signals. MGCD516 also slows down the growth of new blood vessels that help tumors to grow and spread. In this study, all enrolled patients will receive the same treatment. Patients are not assigned or randomized to different groups, and no patients will receive a placebo. All patients will receive the study medication, MGCD516, at the same dose and schedule. MGCD516 is an oral medication and is provided as capsules which are taken on a daily basis.

Are you Eligible? (Inclusion Criteria)

• Histologically confirmed soft tissue or bone sarcoma. All subtypes of soft tissue and bone sarcoma are considered eligible for this study.
• Disease must be locally advanced and unresectable or metastatic.
• Patients must have been treated with at least one prior systemic regimen for sarcoma.
• Patients must evidence of disease progression, either clinically or radiographically, within the 6 weeks prior to study enrollment, as determined by the principal investigator.