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

PHASE3TerminatedINTERVENTIONAL
Enrollment

233

Participants

Timeline

Start Date

August 27, 2013

Primary Completion Date

May 18, 2018

Study Completion Date

March 6, 2019

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)

Trial Locations (45)

5000

Research Site, Odense C

10029

Research Site, New York

10065

Research Site, New York

19014

Research Site, Philadelphia

20010

Research Site, Washington D.C.

27710

Research Site, Durham

31059

Research Site, Toulouse

33076

Research Site, Bordeaux

35233

Research Site, Birmingham

41076

Research Site, Caen

45122

Research Site, Essen

45219

Research Site, Cincinnati

49033

Research Site, Angers

56124

Research Site, Pisa

72205

Research Site, Little Rock

80045

Research Site, Aurora

80131

Research Site, Napoli

86156

Research Site, Augsburg

90048

Research Site, Los Angeles

90502

Research Site, Torrance

94805

Research Site, Villejuif

95122

Research Site, Catania

97239

Research Site, Portland

02114

Research Site, Boston

02215

Research Site, Boston

37232-8148

Research Site, Nashville

14784-400

Research Site, Barretos

Unknown

Research Site, Porto Alegre

Research Site, Ribeirão Preto

Research Site, Rio de Janeiro

Research Site, São José do Rio Preto

Research Site, São Paulo

Research Site, Lyon

04103

Research Site, Leipzig

00161

Research Site, Roma

44-101

Research Site, Gliwice

25-734

Research Site, Kielce

60-355

Research Site, Poznan

02-507

Research Site, Warsaw

02-781

Research Site, Warsaw

95-100

Research Site, Zgierz

413 45

Research Site, Gothenburg

581 85

Research Site, Linköping

221 85

Research Site, Lund

171 76

Research Site, Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY