Preliminary results of the first clinical trial initiated by ITOG have been evaluated, marking a major accomplishment for ITOG. The goal of this multi-institution clinical trial, led by Dr. Manisha H. Shah from Ohio State University, is to examine whether patients who had progression of their thyroid cancer on a VEGFR inhibitor benefit from treatment with cabozantinib. Dr. Shah reported the initial findings this October at the 15th International Thyroid Congress in Lake Buena Vista, Florida. The abstract of her talk was titled: Cabozantinib in Patients with Radioiodine-Refractory Differentiated Thyroid Cancer Who Progressed on Prior VEGFR-Targeted Therapy: Results of NCI- and ITOG-sponsored multicenter phase II clinical trial.

This investigator-initiated clinical trial is truly a collaborative endeavor and every site has participated actively in the process. These efforts have facilitated an impressive timeline in which it took less than two years from the initiation of the clinical trial, October 2013, to full enrollment in January of 2015. The 25 patients enrolled in the trial are divided fairly evenly among the participating cancer centers. A total of five patients are enrolled at Ohio State University Comprehensive Cancer Center and the remaining 20 patients are at Massachusetts General Hospital (4 patients), Mayo Clinic Florida (4 patients), MD Anderson Cancer Center (5 patients), University of Chicago (6 patients), and Medstar Washington Hospital Center (1 patient).

NCI9312/OSU12154/RU241210I is an open label, phase II trial to determine whether patients with radioiodine-refractory, differentiated thyroid cancer (DTC), who progressed on first-line therapy with a VEGFR antagonist, benefit from treatment with cabozantinib. ITOG’s mission is to catalyze a cure for thyroid cancer and this clinical trial is coordinated by the Academic and Community Cancer Research United (ACCRU) and is funded by Cancer Therapy Evaluation Program (CTEP) of National Cancer Institute (NCI), a peer-reviewed federally sponsored group. Additional funding for the clinical trial and correlative science is provided by ITOG, which is a 501(c)(3) tax-exempt public charity.

Cabozantinib is an oral multikinase inhibitor targeting several angiogenic proteins such as VEGFR, PDGFR, c-met, as well as RET kinase. The Food and Drug Administration of United States recently approved cabozantinib for patients with progressive medullary thyroid cancer. ITOG is testing this drug for its use in a 2nd line setting for patients with differentiated thyroid cancer who progress on first line VEGFR targeted therapy. Given that c-met may be critical in causing failure of VEGFR targeted therapy, cabozantinib is chosen for testing in 2nd line setting due to its unique activity against c-met. During the trial, the study drug will be administered orally once daily until cancer progression or intolerance. The study will also examine if this drug is effective against bony metastasis.

More information related to the trial is available at http://clinicaltrials.gov/ct2/show/NCT01811212?term=cabozantinib+in+thyr...

 For questions related to the trial please contact Manisha H. Shah, MD at 614-293-4680 or manisha.shah@osumc.edu.