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Clinical Trial VICCTHN1318

Title

A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients with Differentiated Thyroid Cancer

Principal Investigator(s)

Leon Parks

Details

  • Protocol No. VICCTHN1318
  • Open Date: 09/19/2013
  • Staging: Phase III
  • Age Group: Adults
  • Scope: International
  • Objective: To compare the efficacy of selumetinib with radioactive iodine therapy (RAI), versus placebo with RAI, by assessment of complete remission rate at 18 months post RAI treatment in the overall study population. To compare the efficacy of selumetinib with RAI, versus placebo with RAI, by assessment of complete remission rate at 18 months post RAI treatment in a subgroupof patients with tumours known to be mutation positive for BRAF or NRAS.
  • Disease Sites: Thyroid
  • Therapies: Hormonal Therapy; Molecular Targeted Agents / Immunotherapy / Biologics; Radiotherapy
  • Drugs: Selumetinib; Thyrogen
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01843062
  • Secondary Protocol No: D1532C00065

Description

Patients are being asked to take part in this research study because they have been diagnosed with thyroid cancer. The standard treatment for your type of thyroid cancer is surgery, followed by radioactive iodine. Their study doctor believes that they may benefit from the addition of selumetinib (study medicine) to the radioactive iodine that they will be taking for their thyroid cancer. Selumetinib is an experimental drug that works by blocking a protein in their body called MEK. Other patients with thyroid cancer have received selumetinib before and in some of those patients, selumetinib may have helped their radioactive iodine work better. Patients doctor believes that their thyroid cancer has a chance of going away for good (being in -complete remission) with the standard therapy of surgery and radioactive iodine only but that their chance to be in remission may be better with the addition of selumetininb. Neithe rtheir doctor nor anyone else knows whether selumetinib will make it more or less likely for their cancer to go away.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
Differentiated thyroid cancer Tumor >4 cm, or Gross extra-thyroid extension, or 1 lymph node >1 cm, or 5 or more lymph nodes of any size Previous thyroidectomy Must be able to receive radioactive iodine therapy Must be able to receive Thyroid Stimulating Hormone suppression
Exclusion Criteria:
Metastaic disease Anaplastic thyroid cancer, medullary thyroid cancer or Hurthle cell carcinoma Presence of anti-Tg antibodies Previous treatment with any radiation Unresolved toxicity ≥ common terminology criteria for adverse event Grade 2