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

NCT01843062 · ASTRA Phase 3Terminated

Lead sponsor
AstraZeneca (Industry)
Enrollment
233 (actual)
Start date
27 Aug 2013
Primary completion
18 May 2018 (actual)
Study completion
6 Mar 2019
Last update posted
28 Aug 2019

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • Selumetinib Drug
  • Placebo Drug
  • Radioactive Iodine Therapy Drug

Conditions and primary outcome

  • Differentiated Thyroid Cancer

Primary outcome

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

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT01843062 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. 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
    Measure
    Number
    Unit
    Percentage of participants

    • Selumetinib 75 mg BD + RAI vs Placebo + RAISuperiority

      Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.

      Estimate
      1.07Odds Ratio (OR)
      95% CI, two-sided
      0.61 to 1.87
      p-value
      0.8205
      Method
      Regression, Logistic

Serious adverse events

Time frame: Includes adverse events (AEs) with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of selumetinib/placebo. Overall timeframe for collection of AEs was up to 66 days from the first dose.

Participants with serious adverse events per group for ASTRA, as posted
GroupAffectedAt risk
Selumetinib 75 mg BD + RAI7154
Placebo + RAI077

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

1 on PubMed

  1. Selumetinib Plus Adjuvant Radioactive Iodine in Patients With High-Risk Differentiated Thyroid Cancer: A Phase III, Randomized, Placebo-Controlled Trial (ASTRA).

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022 Jun 10

    PubMed 35192411 (opens in a new tab)DOI 10.1200/JCO.21.00714 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.