Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer (ASTRA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01843062
First received: March 14, 2013
Last updated: April 2, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Differentiated Thyroid Cancer
Drug: Selumetinib
Drug: Placebo
Drug: Radioactive Iodine Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Complete remission rate in overall study population [ Time Frame: Measured at 18 months post radioactive iodine treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical remission rate in overall study population [ Time Frame: Measured at 18 months post radioactive iodine treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 304
Study Start Date: August 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01843062

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 877-400-4656 astrazeneca@emergingmed.com

  Show 50 Study Locations
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: Ian Smith, M.D., PHD 11G34,Mereside,Alderley Park,Macclesfield, Cheshire, England
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01843062     History of Changes
Other Study ID Numbers: D1532C00065, EudraCT 2013-000423-14
Study First Received: March 14, 2013
Last Updated: April 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
Sweden: Medical Products Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Brazil: National Health Surveillance Agency
Denmark: Danish Health and Medicines Authority

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

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014