NCT01843062

Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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 Differentiated Thyroid Cancer.

Conditions

• Differentiated Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Selumetinib	3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period
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)

Timeline

• Start date: 2013-08-27
• Primary completion: 2018-05-18
• Completion: 2019-03-06
• First posted: 2013-04-30
• Last updated: 2019-08-28
• Results posted: 2019-04-22

Locations

45 sites across 8 countries: United States, Brazil, Denmark, France, Germany, Italy, Poland, Sweden