In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat

Clinical Trials (PDQ®)

Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryD1532C00065
EudraCT 2013-000423-14, NCT01843062

Trial Description

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.

Further Study 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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

AstraZeneca Pharmaceuticals LP

Alan Loh HoPrincipal Investigator

Gabriella Mariani, M.D., PHDStudy Director

AstraZeneca Clinical Study InformationPh: 800-236-9933
  Email: ClinicalTrialTransparency@astrazeneca.com

Trial Sites

U.S.A.
Alabama
  Birmingham
 Research Site
Arkansas
  Little Rock
 Research Site
California
  Torrance
 Research Site
Colorado
  Aurora
 Research Site
District of Columbia
  Washington
 Research Site
Massachusetts
  Boston
 Research Site
New York
  New York
 Research Site
North Carolina
  Durham
 Research Site
Ohio
  Cincinnati
 Research Site
Oregon
  Portland
 Research Site
Pennsylvania
  Philadelphia
 Research Site
Tennessee
  Nashville
 Research Site
Denmark
  Odense
 Research Site
France
  Angers Cedex 01
 Research Site
  Bordeaux Cedex
 Research Site
  Caen Cedex 5
 Research Site
  Lyon
 Research Site
  Toulouse Cedex
 Research Site
  Villejuif Cedex
 Research Site
Germany
  Augsburg
 Research Site
  Essen
 Research Site
  Leipzig
 Research Site
  Marburg
 Research Site
  Würzburg
 Research Site
Italy
  Catania
 Research Site
  Milano
 Research Site
  Napoli
 Research Site
  Pisa
 Research Site
  Roma
 Research Site
Poland
  Gliwice
 Research Site
  Kielce
 Research Site
  Poznan
 Research Site
  Warszawa
 Research Site
  Zgierz
 Research Site
Sweden
  Göteborg
 Research Site
  Linköping
 Research Site
  Lund
 Research Site
  Stockholm
 Research Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01843062
ClinicalTrials.gov processed this data on September 16, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to TopBack to Top