A Phase II Study of Radioactive Iodine (RAI) with Selumetinib or a Placebo to Treat RAI-Avid Recurrent or Metastatic Thyroid Cancer

Full Title

Randomized Double-Blind Phase II Study of Radioactive Iodine (RAI) in Combination with Placebo or Selumetinib for the Treatment of RAI-Avid Recurrent/Metastatic Thyroid Cancers

Purpose

Radioactive iodine (RAI) is the standard treatment for thyroid cancer. But in some patients, the thyroid cancer does not absorb enough RAI to shrink. Doctors are therefore seeking better ways to improve how RAI treats thyroid cancer.

Selumetinib is an investigational drug that inhibits a protein commonly involved in cancer called MEK. In this study, researchers want to see if adding selumetinib to RAI treatment can make thyroid cancers absorb more RAI, which could lead to more tumor shrinkage. Patients will be randomly assigned to receive RAI plus selumetinib or RAI plus a placebo (inactive pill). Selumetinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have RAI-avid recurrent or metastatic thyroid cancer. ("RAI-avid" means the thyroid cancer takes up radioactive iodine.)
  • At least 6 months must pass between completion of prior RAI therapy and entry into the study. At least 4 weeks must pass since any prior radiation therapy, chemotherapy, or targeted therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alan L. Ho at 646-888-4235.

Protocol

15-097

Phase

II

Investigator

Diseases

Locations