Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer (ASTRA)

August 27, 2019 updated by: AstraZeneca

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

The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

233

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Ribeirão Preto, Brazil
        • Research Site
      • Rio de Janeiro, Brazil
        • Research Site
      • São José do Rio Preto, Brazil
        • Research Site
      • São Paulo, Brazil
        • Research Site
  • Denmark
      • Odense C, Denmark, 5000
        • Research Site
  • France
      • Angers Cedex 01, France, 49033
        • Research Site
      • Bordeaux Cedex, France, 33076
        • Research Site
      • Caen Cedex 5, France, 41076
        • Research Site
      • Lyon, France
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
      • Villejuif Cedex, France, 94805
        • Research Site
  • Germany
      • Augsburg, Germany, 86156
        • Research Site
      • Essen, Germany, 45122
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
  • Italy
      • Catania, Italy, 95122
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Pisa, Italy, 56124
        • Research Site
      • Roma, Italy, 00161
        • Research Site
  • Poland
      • Gliwice, Poland, 44-101
        • Research Site
      • Kielce, Poland, 25-734
        • Research Site
      • Poznań, Poland, 60-355
        • Research Site
      • Warszawa, Poland, 02-781
        • Research Site
      • Warszawa, Poland, 02-507
        • Research Site
      • Zgierz, Poland, 95-100
        • Research Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Research Site
      • Linköping, Sweden, 581 85
        • Research Site
      • Lund, Sweden, 221 85
        • Research Site
      • Stockholm, Sweden, 171 76
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Los Angeles, California, United States, 90048
        • Research Site
      • Torrance, California, United States, 90502
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Research Site
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • New York
      • New York, New York, United States, 10065
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19014
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232-8148
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Selumetinib
Selumetinib plus Radioactive Iodine Therapy
Drug: Selumetinib
3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period
Drug: Radioactive Iodine Therapy
A single oral radioactive iodine dose of 100 mCI(3.7 GBq) 131I (+/-10% at the time of administration)to be administered 30 days after randomization. Additionaly, Thyrogen (Recombinant human TSH) will be used to stimulate iodine uptake according to the manufacturer's recommendation(0.9 mg intramuscular injection once a day for the 2 days prior to the dose of radioactive iodine)
PLACEBO_COMPARATOR: Placebo
Placebo plus Radioactive Iodine Therapy
Drug: Radioactive Iodine Therapy
A single oral radioactive iodine dose of 100 mCI(3.7 GBq) 131I (+/-10% at the time of administration)to be administered 30 days after randomization. Additionaly, Thyrogen (Recombinant human TSH) will be used to stimulate iodine uptake according to the manufacturer's recommendation(0.9 mg intramuscular injection once a day for the 2 days prior to the dose of radioactive iodine)
Drug: Placebo
3 capsules ( to match Selumetinib capsules) orally twice a day for approximately 5 weeks treatment period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set
Time Frame: At 18 months post-RAI treatment

Patients were defined to be in complete remission if all of the following criteria were demonstrated:

  1. Serum thyroglobulin (Tg) levels <1 nanograms / millilitre (ng/mL) during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
  2. No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
  3. No confirmed radiological evidence of thyroid cancer, as assessed by blinded independent central review.
  4. No histopathological evidence of thyroid cancer on fine needle aspiration (FNA)/biopsy when performed, as assessed by investigator site review.
  5. No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment.
At 18 months post-RAI treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive
Time Frame: At 18 months post-RAI treatment

Patients were defined to be in complete remission if all of the following criteria were demonstrated:

  1. Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
  2. No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
  3. No confirmed radiological evidence of thyroid cancer, as assessed by blinded independent central review.
  4. No histopathological evidence of thyroid cancer FNA/biopsy when performed, as assessed by investigator site review.
  5. No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment.
At 18 months post-RAI treatment
Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set
Time Frame: At 18 months post-RAI treatment

Patients were defined to be in clinical remission if all of the following criteria were demonstrated:

  1. Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
  2. No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
  3. No evidence of thyroid cancer on diagnostic whole body scan (WBS), as assessed by blinded independent central review.
  4. No histopathological evidence of thyroid cancer on FNA/biopsy when performed to clarify equivocal ultrasound findings, as assessed by investigator site review.
  5. No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment.
At 18 months post-RAI treatment
Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive
Time Frame: At 18 months post-RAI treatment

Patients were defined to be in clinical remission if all of the following criteria were demonstrated:

  1. Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
  2. No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
  3. No evidence of thyroid cancer on diagnostic WBS, as assessed by blinded independent central review.
  4. No histopathological evidence of thyroid cancer on FNA/biopsy when performed to clarify equivocal ultrasound findings, as assessed by investigator site review.
  5. No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment.
At 18 months post-RAI treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Alan Ho, M.D., PHD, Memorial Sloan Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065.
  • Study Director: Tracy C Cunningham, M.D, Melbourn Science Park, Cambridge Road, Melbourn, Hertfordshire, SG8 6HB, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 27, 2013

Primary Completion (ACTUAL)

May 18, 2018

Study Completion (ACTUAL)

March 6, 2019

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (ESTIMATE)

April 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1532C00065
  • 2013-000423-14 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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