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
18 Years
N/A
Both
Differentiated Thyroid Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Complete remission rate in overall study population
Outcome Time Frame:
Measured at 18 months post radioactive iodine treatment
Safety Issue:
No
Principal Investigator
Alan Ho, M.D., PHD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065.
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
D1532C00065
NCT ID:
NCT01843062
Start Date:
July 2013
Completion Date:
October 2017
Related Keywords:
- Differentiated Thyroid Cancer
- Selumetinib, Differentiated Thyroid Cancer , AZD6244
- Thyroid Neoplasms
- Thyroid Diseases
Name | Location |
|---|---|
| Research Site | Alabaster, Alabama |
| Research Site | Bentonville, Arkansas |
| Research Site | Anaheim, California |
| Research Site | Boulder, Colorado |
| Research Site | Washington, District of Columbia |
| Research Site | Arlington Heights, Illinois |
| Research Site | Beverly, Massachusetts |
| Research Site | Albany, New York |
| Research Site | Asheville, North Carolina |
| Research Site | Akron, Ohio |
| Research Site | Bend, Oregon |
| Research Site | Allentown, Pennsylvania |
| Research Site | Chattanooga, Tennessee |
