Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer (ASTRA)
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ClinicalTrials.gov Identifier: NCT01843062 |
Recruitment Status
:
Active, not recruiting
First Posted
: April 30, 2013
Last Update Posted
: December 5, 2017
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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 |
Estimated Primary Completion Date : | January 8, 2018 |
Estimated Study Completion Date : | August 2, 2019 |
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)
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- Complete remission rate in overall study population [ Time Frame: Measured at 18 months post radioactive iodine treatment ]
- Clinical remission rate in overall study population [ Time Frame: Measured at 18 months post radioactive iodine treatment ]
- Clinical remission rate in sub-group of patients with tumours known to be mutation positive for v-raf murine sarcoma viral oncogene homolog B1 or NRAS [ Time Frame: Measured at 18 months post radioactive iodine treatment ]
- Frequency of adverse events graded according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE)" [ Time Frame: Measured throughout the study until 3 years post radioactive iodine treatment ]
- Selumetinib concentration profile over time [ Time Frame: In total 8 blood samples will be collected: 4 samples on pre defined time windows on Day1, and 4 samples on Day 29 or Day 30 ]
- N-desmethyl selumetinib concentration profile over time [ Time Frame: in total 8 blood samples will be collected: 4 samples on pre defined time windows on Day1, and 4 samples on Day 29 or Day 30 ]
- Selumetinib amide concentration profile over time [ Time Frame: in total 8 blood samples will be collected: 4 samples on pre defined time windows on Day1, and 4 samples on Day 29 or Day 30 ]
- Complete remission rate in sub-group of patients with tumours known to be mutation positive for v-raf murine sarcoma viral oncogene homolog B1 or NRAS [ Time Frame: Measured at 18 months post radioactive iodine treatment ]

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Ages Eligible for Study: | 18 Years to 130 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Principal Investigator: | Alan Ho, M.D., PHD | Memorial Sloan Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065. | |
Study Director: | Gabriella Mariani, M.D., PHD | 11G34,Mereside,Alderley Park,Macclesfield, Cheshire, England |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01843062 History of Changes |
Other Study ID Numbers: |
D1532C00065 EudraCT 2013-000423-14 |
First Posted: | April 30, 2013 Key Record Dates |
Last Update Posted: | December 5, 2017 |
Last Verified: | December 2017 |
Keywords provided by AstraZeneca:
Selumetinib, Differentiated Thyroid Cancer , AZD6244 |
Additional relevant MeSH terms:
Thyroid Diseases Thyroid Neoplasms Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Iodine |
Cadexomer iodine Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |