December 2009 clinical trials update

By Jim Hughes
Clinical Trials Coordinator

United States

RAD001 in combination with CP- 751,871 in patients with advanced sarcomas and other malignant neoplasms (NCT00927966)

An mTOR inhibitor (RAD001) and an IGF-1R inhibitor (CP-751,871) are combined in this phase I trial, which is now recruiting at Dana-Farber Cancer Institute (DFCI).

The entry criteria allow GIST and state that patients “...on approved tyrosine kinase inhibitors must be off therapy two weeks prior to study entry.”

This trial is for age 18 and over and might be a good option for wild-type GIST patients whose tumors test for higher levels of IGF-1R and who have exhausted other options. RAD001 (Everolimus, Afinitor) has previously been used off label and in trials for GIST. The Principal Investigator is Dr. Suzanne George.

Contact: Suzanne George at 617-632- 5204, or Dr. Richard Quek at richard_ quek@dfci.harvard.edu.

Imatinib and sunitinib in treating GIST patients (NCT00573404)

This phase I trial in resistant GIST at Vanderbilt University is now ongoing and no longer recruiting.

International

Nilotinib 800 Mg and imatinib 800 Mg for The treatment of GIST patients refractory to imatinib 400 Mg (LANGIST) (NCT00751036)

Seventeen new sites have been added to this phase III trial comparing imatinib and nilotinib in resistant GIST patients. The new sites are now recruiting in Latin America, the Republic of Korea and Thailand.

Dasatinib as first-line therapy in treating GIST patients (NCT00568750)

This phase II trial for newly diagnosed GIST patients has added 17 sites and contacts in Finland, France, Germany and Switzerland.

To view the latest clinical trials, visit: http://www.liferaftgroup.org/treat/trials.html