The first clinical trial initiated by ITOG in the fall of 2013 has completed its planned enrollment, 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.
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 to full enrollment. 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. It was recently approved by the Food and Drug Administration of United States 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.
Twenty-five patients are currently undergoing treatment and it is anticipated that analysis of the primary outcomes and will be completed in the next 6 months.
More information related to the trial is available at http://clinicaltrials.gov/ct2/show/NCT01811212?term=cabozantinib+in+thyroid&rank=2 For questions related to the trial please contact Manisha H. Shah, MD at 614-293-4680 or firstname.lastname@example.org