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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 : Active, not recruiting
First Posted : April 30, 2013
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

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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
Estimated Study Completion Date : April 5, 2019

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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)




Primary Outcome Measures :
  1. Complete remission rate in overall study population [ Time Frame: Measured at 18 months post radioactive iodine treatment ]
    To compare the efficacy of selumetinib with radioactive iodine therapy (RAI), versus placebo with RAI, by assessment of complete remission rate at 18 months post RAI treatment in the intention to treat (ITT) study population.


Secondary Outcome Measures :
  1. Clinical remission rate in overall study population [ Time Frame: Measured at 18 months post radioactive iodine treatment ]
    To compare the efficacy of selumetinib with RAI, versus placebo with RAI by assessment of clinical remission rate at 18 months post RAI treatment in the ITT study population

  2. 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 ]
  3. Frequency of adverse events graded according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE)" [ Time Frame: Measured throughout the study up to 3 years post radioactive iodine treatment ]
    To assess the safety and tolerability of selumetinib with RAI compared to placebo with RAI.

  4. 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 ]
    To investigate the pharmacokinetics (PK) of selumetinib and N-desmethyl selumetinib when administered to patients with differentiated thyroid cancer.

  5. 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 ]
    To investigate the pharmacokinetics (PK) of selumetinib and N-desmethyl selumetinib when administered to patients with differentiated thyroid cancer.

  6. 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 ]
  7. 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 ]
    To compare the efficacy of selumetinib with RAI, versus placebo with RAI, by assessment of complete remission rate at 18 months post RAI treatment in a sub-group of patients with tumours known to be mutation positive for BRAF or NRAS



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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


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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

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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
Last Update Posted: December 27, 2018
Last Verified: December 2018

Keywords provided by AstraZeneca:
Selumetinib, Differentiated Thyroid Cancer , AZD6244

Additional relevant MeSH terms:
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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
Nutrients
Growth Substances
Physiological Effects of Drugs