Status:
TERMINATED
Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Differentiated Thyroid Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
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.
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 Differe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2019
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT01843062
Start Date
August 27 2013
End Date
March 6 2019
Last Update
August 28 2019
Active Locations (45)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Little Rock, Arkansas, United States, 72205
3
Research Site
Los Angeles, California, United States, 90048
4
Research Site
Torrance, California, United States, 90502