Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer
Conditions
Differentiated Thyroid Cancer
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
Selumetinib, Differentiated Thyroid Cancer , AZD6244
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Selumetinib Type: Drug
Name: Placebo Type: Drug
Name: Radioactive Iodine Therapy Type: Drug
Overall Status
Recruiting
Summary
The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Research Site
Birmingham, Alabama, United States
Status: Recruiting
Contact: Amy Warriner - 205-934-4112 - warriner@uab.edu
Research Site
Little Rock, Arkansas, United States
Status: Recruiting
Contact: Donald Bodenner - 501-944-5254 - BodennerDonald@uams.edu
Research Site
Los Angeles, California, United States
Status: Recruiting
Contact: Wendy Sacks - 310-423-5140 - sacksw@cshs.org
Research Site
Torrance, California, United States
Status: Recruiting
Contact: Andrew Gianoukakis - 310-222-8172 - agianoukakis@labiomed.org
Research Site
Aurora, Colorado, United States
Status: Recruiting
Contact: Joshua Klopper - 303-724-1454 - joshua.klopper@ucdenver.edu
Research Site
Washington, District of Columbia, United States
Status: Recruiting
Contact: Kenneth Burman - 202-877-8839 - kenneth.d.burman@medstar.net
Research Site
Tampa, Florida, United States
Status: Not yet recruiting
Contact: Brain McIver - 813-745-3066 - Bryan.McIver@moffitt.org
Research Site
Chicago, Illinois, United States
Status: Withdrawn
Research Site
Boston, Massachusetts, United States
Status: Recruiting
Contact: Lori Wirth - 617-632-5990 - Lori_Wirth@dfci.harvard.edu
Research Site
Boston, Massachusetts, United States
Status: Recruiting
Contact: Lori Wirth - 617-726-8748 - Lori_Wirth@dfci.harvard.edu
Research Site
New York, New York, United States
Status: Recruiting
Contact: Alan Ho - 646-888-4235 - hoa@mskcc.org
Research Site
New York, New York, United States
Status: Recruiting
Contact: William Inabnet - 212-241-6918 - william.inabnet@mountsinai.org
Research Site
Durham, North Carolina, United States
Status: Recruiting
Contact: Julie Sosa - 919-668-1767 - julie.sosa@duke.edu
Research Site
Cincinnati, Ohio, United States
Status: Recruiting
Contact: David Steward - 513-475-8400 - STEWARDD@UCMAIL.UC.EDU
Research Site
Portland, Oregon, United States
Status: Recruiting
Contact: Matthew Taylor - 503-494-8534 - taylmatt@ohsu.edu
Research Site
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Marcia Brose - 215-615-6519 - brosem@mail.med.upenn.edu
Research Site
Charleston, South Carolina, United States
Status: Recruiting
Contact: Keisuke Shirai - 843-792-4271 - shirai@musc.edu
Research Site
Nashville, Tennessee, United States
Status: Recruiting
Contact: Leon Parks - 615-343-8332 - lee.parks@vanderbilt.edu
Research Site
Marilia, Brazil
Status: Withdrawn
Research Site
Porto Alegre, Brazil
Status: Recruiting
Research Site
Ribeirão Preto, Brazil
Status: Recruiting
Research Site
Rio de Janeiro, Brazil
Status: Recruiting
Research Site
Sao Paulo, Brazil
Status: Withdrawn
Research Site
São José do Rio Preto, Brazil
Status: Recruiting
Research Site
São Paulo, Brazil
Status: Recruiting
Research Site
Odense, Denmark
Status: Recruiting
Research Site
Angers Cedex 01, France
Status: Recruiting
Research Site
Bordeaux Cedex, France
Status: Recruiting
Research Site
Caen Cedex 5, France
Status: Recruiting
Research Site
Lyon, France
Status: Recruiting
Research Site
Paris Cedex 10, France
Status: Withdrawn
Research Site
Toulouse Cedex, France
Status: Recruiting
Research Site
Villejuif Cedex, France
Status: Recruiting
Research Site
Augsburg, Germany
Status: Recruiting
Research Site
Essen, Germany
Status: Recruiting
Research Site
Leipzig, Germany
Status: Recruiting
Research Site
Marburg, Germany
Status: Recruiting
Research Site
Würzburg, Germany
Status: Recruiting
Research Site
Catania, Italy
Status: Recruiting
Research Site
Milano, Italy
Status: Recruiting
Research Site
Napoli, Italy
Status: Recruiting
Research Site
Pisa, Italy
Status: Recruiting
Research Site
Roma, Italy
Status: Recruiting
Research Site
Siena, Italy
Status: Withdrawn
Research Site
Gliwice, Poland
Status: Recruiting
Research Site
Kielce, Poland
Status: Recruiting
Research Site
Poznań, Poland
Status: Recruiting
Research Site
Warszawa, Poland
Status: Recruiting
Research Site
Zgierz, Poland
Status: Recruiting
Research Site
Göteborg, Sweden
Status: Recruiting
Research Site
Linköping, Sweden
Status: Recruiting
Research Site
Lund, Sweden
Status: Recruiting
Research Site
Stockholm, Sweden
Status: Recruiting
Start Date
August 2013
Completion Date
March 2019
Sponsors
AstraZeneca
Source
AstraZeneca
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page