A Phase II Trial of LBH589 in Patients With Metastatic Medullary Thyroid Cancer and Radioactive Iodine Resistant Differentiated Thyroid Cancer
Medullary thyroid cancer (MTC) is a neuroendocrine tumor and accounts for 3-5% of cases of
thyroid cancer. The majority of patients with MTC do not present with early stage disease.
Differentiated thyroid cancer (DTC) accounts for >90% of all thyroid cancers. In a sub-set
of patients, thyroid cells become resistant to I-131 radioiodine therapy and subsequently
develop distant metastases. In both MTC and DTC, systemic chemotherapy for metastatic
disease is largely ineffective.
LBH589 is a histone deacetylase (HDAC) with recently demonstrated activity to inhibit the
Notch1 signaling pathway in MTC cancer cells and suppress tumor cell proliferation in DTC
cancer cells. This clinical trial will evaluate the tumor response rate of LBH589 in
patients with metastatic MTC or radioactive iodine resistant DTC.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate to LBH589.
Every 8 weeks.
Anne Traynor, M.D.
University of Wisconsin, Madison
United States: Food and Drug Administration
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|University of Wisconsin - Madison||Madison, Wisconsin 53792|
|St. Vincent Regional Cancer Center CCOP||Green Bay, Wisconsin 54301|