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A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer

Study acronym: EXAMINER
StatusActive, Not Recruiting
PhasePhase 4
SponsorExelixis
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: Sep 2, 2025 Start date: Dec 2014 to Feb 25, 2015 · Primary endpoint revised · Primary completion date: Jul 2020 to Jul 15, 2020 · 2 morev22 Show 5 more changesShow less
    • Start date: Dec 2014 to Feb 25, 2015
    • Primary endpoint revised
    • Primary completion date: Jul 2020 to Jul 15, 2020
    • Completion date: Dec 2023 to Jan 2035
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment target: estimated 250 to confirmed 247 Study sites: 50 to 49v21 Show 1 more changeShow less
    • Study sites: 50 to 49
  3. Re-verified, no change to tracked fieldsv20
  4. Completion date: Dec 2022 to Dec 2023v19
  5. 4 versions Re-verified since Jun 21, 2021, no change to tracked fieldsv15-v18
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date changed from estimate of Sep 2020 to Jul 2020 Completion date: Jun 2021 to Dec 2022v14 Show 1 more changeShow less
    • Completion date: Jun 2021 to Dec 2022
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: 188 to 250 · Study sites: 52 to 50 · Primary completion date: May 2020 to Sep 2020 · 1 morev13 Show 4 more changesShow less
    • Enrollment target: 188 to 250
    • Study sites: 52 to 50
    • Primary completion date: May 2020 to Sep 2020
    • Completion date: Oct 2020 to Jun 2021
  3. Primary completion date: Sep 30, 2018 to May 2020 Completion date: Mar 31, 2019 to Oct 2020 · Study sites revised (52)v12 Show 2 more changesShow less
    • Completion date: Mar 31, 2019 to Oct 2020
    • Study sites revised (52)

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 48 to 52v11
  5. Study sites: 41 to 48v10
  6. Primary completion date: Sep 2017 to Sep 30, 2018 Study sites: 30 to 41 · Completion date: Mar 2018 to Mar 31, 2019v9 Show 2 more changesShow less
    • Study sites: 30 to 41
    • Completion date: Mar 2018 to Mar 31, 2019
  7. Study sites: 25 to 30v8
  8. Study sites: 6 to 25v7
  9. Study sites: 3 to 6v6
  10. Study sites: 1 to 3v5
  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v4 Show 1 more changeShow less
    • Study sites: 0 to 1
  12. Enrollment target: 112 to 188 Primary completion date: Jun 2016 to Sep 2017 · Start date: Jul 2014 to Dec 2014 · Completion date: Sep 2017 to Mar 2018 · 3 morev3 Show 6 more changesShow less
    • Primary completion date: Jun 2016 to Sep 2017
    • Start date: Jul 2014 to Dec 2014
    • Completion date: Sep 2017 to Mar 2018
    • Interventions: Cabozantinib (XL184) 140 mg (Drug), Cabozantinib (XL184) lower dose (Drug), Placebo capsule (Drug), Placebo tablet (Drug) to Cabozantinib (XL184) 140 mg (Drug), Cabozantinib (XL184) 60 mg (Drug), Placebo capsule (Drug), Placebo tablet (Drug)
    • Eligibility criteria expanded, about 142 words
    • Secondary endpoints: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  13. Start date: Dec 2013 to Jul 2014v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Exelixis
25 trials monitored
See 2 trials at risk
Thyroid Cancer
387 trials monitored
See 23 trials at risk
The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.
Trial Details
NCT Number NCT01896479
Lead Sponsor Exelixis
Conditions Medullary Thyroid Cancer
Enrollment 247 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov