- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01843062
Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer (ASTRA)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Barretos, Brazil, 14784-400
- Research Site
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Porto Alegre, Brazil
- Research Site
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Ribeirão Preto, Brazil
- Research Site
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Rio de Janeiro, Brazil
- Research Site
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São José do Rio Preto, Brazil
- Research Site
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São Paulo, Brazil
- Research Site
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Odense C, Denmark, 5000
- Research Site
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Angers Cedex 01, France, 49033
- Research Site
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Bordeaux Cedex, France, 33076
- Research Site
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Caen Cedex 5, France, 41076
- Research Site
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Lyon, France
- Research Site
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Toulouse Cedex 9, France, 31059
- Research Site
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Villejuif Cedex, France, 94805
- Research Site
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Augsburg, Germany, 86156
- Research Site
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Essen, Germany, 45122
- Research Site
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Leipzig, Germany, 04103
- Research Site
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Catania, Italy, 95122
- Research Site
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Napoli, Italy, 80131
- Research Site
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Pisa, Italy, 56124
- Research Site
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Roma, Italy, 00161
- Research Site
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Gliwice, Poland, 44-101
- Research Site
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Kielce, Poland, 25-734
- Research Site
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Poznań, Poland, 60-355
- Research Site
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Warszawa, Poland, 02-781
- Research Site
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Warszawa, Poland, 02-507
- Research Site
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Zgierz, Poland, 95-100
- Research Site
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Göteborg, Sweden, 413 45
- Research Site
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Linköping, Sweden, 581 85
- Research Site
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Lund, Sweden, 221 85
- Research Site
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Stockholm, Sweden, 171 76
- Research Site
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Alabama
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Birmingham, Alabama, United States, 35233
- Research Site
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Research Site
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California
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Los Angeles, California, United States, 90048
- Research Site
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Torrance, California, United States, 90502
- Research Site
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Colorado
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Aurora, Colorado, United States, 80045
- Research Site
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Research Site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Research Site
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Boston, Massachusetts, United States, 02215
- Research Site
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New York
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New York, New York, United States, 10065
- Research Site
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New York, New York, United States, 10029
- Research Site
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North Carolina
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Durham, North Carolina, United States, 27710
- Research Site
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Ohio
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Cincinnati, Ohio, United States, 45219
- Research Site
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Oregon
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Portland, Oregon, United States, 97239
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19014
- Research Site
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Tennessee
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Nashville, Tennessee, United States, 37232-8148
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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EXPERIMENTAL: Selumetinib
Selumetinib plus Radioactive Iodine Therapy
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3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period
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)
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PLACEBO_COMPARATOR: Placebo
Placebo plus Radioactive Iodine Therapy
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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)
3 capsules ( to match Selumetinib capsules) orally twice a day for approximately 5 weeks treatment period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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Patients were defined to be in complete remission if all of the following criteria were demonstrated:
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At 18 months post-RAI treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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Patients were defined to be in complete remission if all of the following criteria were demonstrated:
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At 18 months post-RAI treatment
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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
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Patients were defined to be in clinical remission if all of the following criteria were demonstrated:
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At 18 months post-RAI treatment
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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
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Patients were defined to be in clinical remission if all of the following criteria were demonstrated:
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At 18 months post-RAI treatment
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Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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