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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

None Provided.

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