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

NCT01843062 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2019-08-28

Study results available
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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.

Conditions

  • Differentiated Thyroid Cancer

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Alan Ho, M.D., PHD · Memorial Sloan Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065.

  • Tracy C Cunningham, M.D · Melbourn Science Park, Cambridge Road, Melbourn, Hertfordshire, SG8 6HB, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-27
Primary Completion
2018-05-18
Completion
2019-03-06

Countries

  • United States
  • Brazil
  • Denmark
  • France
  • Germany
  • Italy
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01843062 on ClinicalTrials.gov