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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Treatment18 and overD1532C00065
NCI-2013-01983, 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:

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

Exclusion 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 / Collaborators

AstraZeneca Pharmaceuticals LP

    Trial Sites

    U.S.A.

    Colorado
    Aurora

    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Joshua Paul Klopper
    Principal Investigator

    Massachusetts
    Charlestown

    Massachusetts General Hospital

    Lori Julin Wirth

    Lori Julin Wirth
    Principal Investigator

    New York
    New York

    Memorial Sloan-Kettering Cancer Center

    Alan Loh Ho
    Principal Investigator

    North Carolina
    Durham

    Duke University Medical Center

    Julie Ann Sosa
    Principal Investigator

    Pennsylvania
    Philadelphia

    University of Pennsylvania/Abramson Cancer Center

    Marcia Brose
    Principal Investigator

    South Carolina
    Charleston

    Medical University of South Carolina

    Keisuke Shirai
    Principal Investigator

    Tennessee
    Nashville

    Vanderbilt University/Ingram Cancer Center

    Parks Leon
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01843062

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.