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

TRIAL STATUS: Active

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 Identifier 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.