A Phase III Study of Vandetanib in Patients with Locally Advanced or Metastatic Papillary Thyroid Cancer Who Cannot Be Successfully Treated with Radioiodine

Protocol
13-245
Full Title
A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA) 300 mg in Patients with Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy
Phase
III
Purpose

Vandetanib is an anticancer drug approved for the treatment of medullary thyroid cancer. It works by inhibiting the growth of the blood vessels that tumors need to grow and spread. In this study, researchers are assessing vandetanib in patients with another type of thyroid cancer called papillary thyroid cancer which cannot be successfully treated with radioiodine therapy (the standard treatment for this disease).

Patients in this study will be randomly assigned to receive vandetanib or a placebo. Patients in the placebo group whose tumors continue to grow may be offered therapy with vandetanib if their doctors feel they may benefit. Vandetanib is a tablet that 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 locally advanced or metastatic differentiated (papillary) thyroid cancer that has returned or persisted despite standard therapy and cannot be cured with surgery, radiation therapy, or other treatments.
  • Patients may not have had prior treatment with other tyrosine kinase inhibitors, such as sorafenib.
  • Patients may not be candidates for radioiodine therapy because they (a) experienced continued tumor growth despite radioiodine therapy, (b) have tumors that do not take up radioiodine, or (c) have already received as much radioiodine as doctors think they can have.
  • At least 4 weeks must pass between completion of prior therapy and entry into the study.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eric Sherman at 646-888-4234.

Disease(s)
Thyroid Cancer
Locations
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