Phase 3 Thyroid Cancer Trial, Completed NCT01321554 Sponsor: Eisai Inc. Condition: Thyroid Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 392 participants across two main phases. In the first (randomised) phase, 261 people received a daily oral dose of lenvatinib (24 mg) and 131 received a placebo (a dummy pill with no active ingredient). A separate follow-on phase allowed an additional 115 participants who had been on placebo to switch to lenvatinib. The trial was primarily measuring how long people went without their disease getting worse — called "progression-free survival" — and also looked at how many people's tumours shrank, and how long people lived overall. The reported data shows that, in the randomised phase, the lenvatinib group went a median (the midpoint value across all participants) of 18.3 months before their disease progressed or they died, compared with 3.6 months in the placebo group. For the secondary measure of tumour response, the reported data shows that approximately 64.8% of participants in the lenvatinib group had their tumours meaningfully shrink (either fully or partially disappear), compared with 1.5% in the placebo group. For overall survival (how long people lived), the data was reported as "not available" — meaning those figures were not provided in the submitted results. A measure of how much lenvatinib was absorbed into the bloodstream was also reported (3,490 ng·h/mL), which is a laboratory measurement and not a clinical outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Thyroid Cancer Trial, Completed

NCT01321554
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with either papillary thyroid cancer or follicular thyroid cancer, confirmed by a lab test on a tissue or cell sample.
  • Your cancer can be measured on a scan, as confirmed by an independent radiology review.
  • Your cancer no longer responds to radioactive iodine (I-131) treatment.
  • Your cancer has shown signs of getting worse within the 12 months before joining the trial (plus a 1-month screening window).
  • You have received either no previous treatments, or just one previous treatment, that targeted a specific part of cancer cell growth (called VEGF or VEGFR targeted therapy).
  • Your kidneys, liver, bone marrow, and blood clotting are all working well enough, as defined by the trial's specific measurements.

Who may not be able to join:

  • You have a type of thyroid cancer called anaplastic or medullary thyroid cancer.
  • You have had two or more previous treatments targeting VEGF or VEGFR.
  • You have received any cancer treatment within the last 21 days, or taken part in another experimental drug trial within the last 30 days before starting the study drug.

Additional criteria to continue into an extended treatment phase (confirm with trial site):

  • You were originally assigned to the placebo group, your cancer was confirmed to be progressing by an independent review, and you have requested to switch to the active study drug (lenvatinib).
  • You still meet the trial's original eligibility requirements at the time of switching.
  • No more than 3 months have passed between confirmation of your cancer progressing and starting the new treatment phase.
  • You have not received any other cancer treatments during the gap between the progression confirmation and starting the new treatment phase.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Facility 1, Saint Leonards, New South Wales
Facility 1, Herston, Queensland
Facility 1, Hobart, Tasmania
Facility 1, Melbourne, Victoria
Facility 1, Heidelberg,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Eisai Inc.
Registry
ClinicalTrials.gov
Start date
17 March 2011
Est. completion
15 November 2013

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇭 Thailand 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Progression Free Survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov