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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Differentiated Thyroid Cancer

Thank you

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 SiteAlabaster, Alabama  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteWashington, District of Columbia  
Research SiteArlington Heights, Illinois  
Research SiteBeverly, Massachusetts  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee