Study Stopped
Study was terminated based on the findings of primary analysis at 18 months post-RAI treatment. Patients pending 3 year follow up had end of study phone call.
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
2 other identifiers
interventional
233
8 countries
45
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2013
Longer than P75 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2013
CompletedFirst Posted
Study publicly available on registry
April 30, 2013
CompletedStudy Start
First participant enrolled
August 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2019
CompletedResults Posted
Study results publicly available
April 22, 2019
CompletedAugust 28, 2019
August 1, 2019
4.7 years
March 14, 2013
March 27, 2019
August 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set
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 Outcomes (3)
Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive
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
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
At 18 months post-RAI treatment
Study Arms (2)
Selumetinib
EXPERIMENTALSelumetinib plus Radioactive Iodine Therapy
Placebo
PLACEBO COMPARATORPlacebo plus Radioactive Iodine Therapy
Interventions
3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period
3 capsules ( to match Selumetinib capsules) 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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (45)
Research Site
Birmingham, Alabama, 35233, United States
Research Site
Little Rock, Arkansas, 72205, United States
Research Site
Los Angeles, California, 90048, United States
Research Site
Torrance, California, 90502, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Washington D.C., District of Columbia, 20010, United States
Research Site
Boston, Massachusetts, 02114, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
New York, New York, 10029, United States
Research Site
New York, New York, 10065, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Philadelphia, Pennsylvania, 19014, United States
Research Site
Nashville, Tennessee, 37232-8148, United States
Research Site
Barretos, 14784-400, Brazil
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
Odense C, 5000, Denmark
Research Site
Angers, 49033, France
Research Site
Bordeaux, 33076, France
Research Site
Caen, 41076, France
Research Site
Lyon, France
Research Site
Toulouse, 31059, France
Research Site
Villejuif, 94805, France
Research Site
Augsburg, 86156, Germany
Research Site
Essen, 45122, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Catania, 95122, Italy
Research Site
Napoli, 80131, Italy
Research Site
Pisa, 56124, Italy
Research Site
Roma, 00161, Italy
Research Site
Gliwice, 44-101, Poland
Research Site
Kielce, 25-734, Poland
Research Site
Poznan, 60-355, Poland
Research Site
Warsaw, 02-507, Poland
Research Site
Warsaw, 02-781, Poland
Research Site
Zgierz, 95-100, Poland
Research Site
Gothenburg, 413 45, Sweden
Research Site
Linköping, 581 85, Sweden
Research Site
Lund, 221 85, Sweden
Research Site
Stockholm, 171 76, Sweden
Related Publications (1)
Ho AL, Dedecjus M, Wirth LJ, Tuttle RM, Inabnet WB 3rd, Tennvall J, Vaisman F, Bastholt L, Gianoukakis AG, Rodien P, Paschke R, Elisei R, Viola D, So K, Carroll D, Hovey T, Thakre B, Fagin JA; ASTRA investigator group. Selumetinib Plus Adjuvant Radioactive Iodine in Patients With High-Risk Differentiated Thyroid Cancer: A Phase III, Randomized, Placebo-Controlled Trial (ASTRA). J Clin Oncol. 2022 Jun 10;40(17):1870-1878. doi: 10.1200/JCO.21.00714. Epub 2022 Feb 22.
PMID: 35192411DERIVED
Related Links
MeSH Terms
Interventions
Limitations and Caveats
The study was terminated early (based on the findings of the primary analysis at 18 months post-RAI treatment) and all randomised patients who had not yet completed their 3-year follow-up visit were instead to have an end of study phone call.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2013
First Posted
April 30, 2013
Study Start
August 27, 2013
Primary Completion
May 18, 2018
Study Completion
March 6, 2019
Last Updated
August 28, 2019
Results First Posted
April 22, 2019
Record last verified: 2019-08