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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 : 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
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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

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 Design
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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

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Arms and Interventions
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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: 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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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

Contacts and Locations
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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


  Show 45 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
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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:
Study Protocol  [PDF] January 24, 2013
Statistical Analysis Plan  [PDF] April 4, 2018

More Information
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Additional Information:
Statistical Analysis Plan-edition 4_Redacted  This link exits the ClinicalTrials.gov site Redacted CSP  This link exits the ClinicalTrials.gov site Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01843062     History of Changes
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:
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
Iodine
 Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs