Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer (ASTRA)
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| ClinicalTrials.gov Identifier: NCT01843062 |
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Recruitment Status :
Terminated
(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.)
First Posted : April 30, 2013
Results First Posted : April 22, 2019
Last Update Posted : August 28, 2019
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Differentiated Thyroid Cancer | Drug: Selumetinib Drug: Placebo Drug: Radioactive Iodine Therapy | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 233 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | August 27, 2013 |
| Actual Primary Completion Date : | May 18, 2018 |
| Actual Study Completion Date : | March 6, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Selumetinib
Selumetinib plus Radioactive Iodine Therapy
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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) |
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Placebo Comparator: Placebo
Placebo plus Radioactive Iodine Therapy
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Drug: Placebo
3 capsules ( to match Selumetinib capsules) 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) |
Primary Outcome Measures :
- 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:
- 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.
- No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
- No confirmed radiological evidence of thyroid cancer, as assessed by blinded independent central review.
- No histopathological evidence of thyroid cancer on fine needle aspiration (FNA)/biopsy when performed, as assessed by investigator site review.
- No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment.
Secondary Outcome Measures :
- 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:
- Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
- No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
- No confirmed radiological evidence of thyroid cancer, as assessed by blinded independent central review.
- No histopathological evidence of thyroid cancer FNA/biopsy when performed, as assessed by investigator site review.
- No further thyroid cancer therapy was administered in the first 18 months following the initial 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:
- Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
- No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
- No evidence of thyroid cancer on diagnostic whole body scan (WBS), as assessed by blinded independent central review.
- No histopathological evidence of thyroid cancer on FNA/biopsy when performed to clarify equivocal ultrasound findings, as assessed by investigator site review.
- No further thyroid cancer therapy was administered in the first 18 months following the initial 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:
- Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
- No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
- No evidence of thyroid cancer on diagnostic WBS, as assessed by blinded independent central review.
- No histopathological evidence of thyroid cancer on FNA/biopsy when performed to clarify equivocal ultrasound findings, as assessed by investigator site review.
- No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment.
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| Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843062
Locations
| United States, Alabama | |
| Research Site | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arkansas | |
| Research Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Research Site | |
| Los Angeles, California, United States, 90048 | |
| Research Site | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| Research Site | |
| Aurora, Colorado, United States, 80045 | |
| United States, District of Columbia | |
| Research Site | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Massachusetts | |
| Research Site | |
| Boston, Massachusetts, United States, 02114 | |
| Research Site | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| Research Site | |
| New York, New York, United States, 10029 | |
| Research Site | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Research Site | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Research Site | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oregon | |
| Research Site | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Research Site | |
| Philadelphia, Pennsylvania, United States, 19014 | |
| United States, Tennessee | |
| Research Site | |
| Nashville, Tennessee, United States, 37232-8148 | |
| Brazil | |
| Research Site | |
| Barretos, Brazil, 14784-400 | |
| Research Site | |
| Porto Alegre, Brazil | |
| Research Site | |
| Ribeirão Preto, Brazil | |
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| Rio de Janeiro, Brazil | |
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| São José do Rio Preto, Brazil | |
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| São Paulo, Brazil | |
| Denmark | |
| Research Site | |
| Odense C, Denmark, 5000 | |
| France | |
| Research Site | |
| 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 | |
| Germany | |
| Research Site | |
| Augsburg, Germany, 86156 | |
| Research Site | |
| Essen, Germany, 45122 | |
| Research Site | |
| Leipzig, Germany, 04103 | |
| Italy | |
| Research Site | |
| Catania, Italy, 95122 | |
| Research Site | |
| Napoli, Italy, 80131 | |
| Research Site | |
| Pisa, Italy, 56124 | |
| Research Site | |
| Roma, Italy, 00161 | |
| Poland | |
| Research Site | |
| Gliwice, Poland, 44-101 | |
| Research Site | |
| Kielce, Poland, 25-734 | |
| Research Site | |
| Poznań, Poland, 60-355 | |
| Research Site | |
| Warszawa, Poland, 02-507 | |
| Research Site | |
| Warszawa, Poland, 02-781 | |
| Research Site | |
| Zgierz, Poland, 95-100 | |
| Sweden | |
| Research Site | |
| Göteborg, Sweden, 413 45 | |
| Research Site | |
| Linköping, Sweden, 581 85 | |
| Research Site | |
| Lund, Sweden, 221 85 | |
| Research Site | |
| Stockholm, Sweden, 171 76 | |
Sponsors and Collaborators
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 |
Study Documents (Full-Text)
Documents provided by AstraZeneca:
Documents provided by AstraZeneca:
Study Protocol [PDF] January 24, 2013
Statistical Analysis Plan [PDF] April 4, 2018
Additional Information:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01843062 |
| Other Study ID Numbers: |
D1532C00065 2013-000423-14 ( EudraCT Number ) |
| First Posted: | April 30, 2013 Key Record Dates |
| Results First Posted: | April 22, 2019 |
| Last Update Posted: | August 28, 2019 |
| Last Verified: | August 2019 |
Keywords provided by AstraZeneca:
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Selumetinib, Differentiated Thyroid Cancer , AZD6244 |
Additional relevant MeSH terms:
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Thyroid Neoplasms Thyroid Diseases Endocrine System Diseases Endocrine Gland Neoplasms |
Neoplasms by Site Neoplasms Head and Neck Neoplasms |