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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT01843062
Phase
PHASE3
Status
Terminated

Conditions

  • Differentiated Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Selumetinib — DRUG
    3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period
  • Placebo — DRUG
    3 capsules ( to match Selumetinib capsules) orally twice a day for approximately 5 weeks treatment period
  • Radioactive Iodine Therapy — DRUG
    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)

Study Details

The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.

Key Dates

Start date
Aug 27, 2013
Status verified
Aug 2019
Primary completion
May 18, 2018
Completion
Mar 6, 2019

Study Design

Enrollment
233 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Selumetinib
    Selumetinib plus Radioactive Iodine Therapy
  • Placebo Comparator: Placebo
    Placebo plus Radioactive Iodine Therapy

Primary Outcome Measure

Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set [ Time Frame: At 18 months post-RAI treatment ]

Locations (15)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SiteLittle RockArkansas72205-
Research SiteLos AngelesCalifornia90048-
Research SiteTorranceCalifornia90502-
Research SiteAuroraColorado80045-
Research SiteWashington D.C.District of Columbia20010-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10065-
Research SiteDurhamNorth Carolina27710-
Research SiteCincinnatiOhio45219-
Research SitePortlandOregon97239-
Research SitePhiladelphiaPennsylvania19014-
Research SiteNashvilleTennessee37232-8148-

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