Comparing complete remission after treatment with selumetinib/placebo in patient with differentiated thyroid cancer - ASTRA
Study identifier:D1532C00065
ClinicalTrials.gov identifier:NCT01843062
EudraCT identifier:2013-000423-14
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
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
Medical condition
Differentiated Thyroid Cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Selumetinib, Placebo, Radioactive Iodine Therapy
Sex
All
Actual Enrollment
233
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 27 Aug 2013
Primary Completion Date: 18 May 2018
Study Completion Date: 06 Mar 2019
Study design
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2019 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Selumetinib Selumetinib plus Radioactive Iodine Therapy | Drug: Selumetinib 3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period Other Name: N/A 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) Other Name: N/A |
| Placebo Comparator: Placebo Placebo plus Radioactive Iodine Therapy | Drug: Placebo 3 capsules ( to match Selumetinib capsules) orally twice a day for approximately 5 weeks treatment period Other Name: N/A 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) Other Name: N/A |
Contacts
Investigators
Principal Investigator
Alan Ho
Memorial Sloan Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065.
