Phase 2 Thyroid Cancer Trial, Terminated NCT02657369 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 (NCT02657369) enrolled 34 participants, all of whom received a daily dose of lenvatinib (24 mg). The trial was measuring how a tumour responded to the treatment, how long participants lived without their disease getting worse, and how long participants survived overall. Notably, the reported data shows that none of the 34 participants were recorded as having formally "completed" the study — all 34 were listed as "not completed," which may reflect that the study was terminated early by the sponsor. The reported data shows that the primary outcome — the proportion of participants whose tumours showed a meaningful reduction in size (called the "objective response rate") — was 3%, meaning roughly 1 in 34 participants met that threshold. For the secondary outcomes, around 36% of participants were reported to be alive and without their disease progressing at the 12-week mark. At six months, approximately 41% of participants were reported to still be alive. The reported middle-point figure (called the "median") for how long participants went without disease progression was 2.6 months, and the median for overall survival was 3.2 months. 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 2 Thyroid Cancer Trial, Terminated

NCT02657369
Terminated Phase 2 🇦🇺 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 Anaplastic Thyroid Cancer (ATC), confirmed by a tissue biopsy (not just a fine needle aspiration alone).
  • A central laboratory review of your cancer diagnosis is required for the study, though it does not have to be completed before you start treatment.
  • You may still be eligible if your cancer started as a different type of thyroid cancer (differentiated thyroid cancer) but has an ATC component, as long as the measurable disease is consistent with ATC.
  • You have had prior chemotherapy (before or after surgery, or to manage advanced disease) for ATC.
  • You have at least one tumor that can be measured by CT or MRI scan, meeting specific size requirements set by the study team.
  • If you have had cancer spread to the brain, you may still qualify if you completed brain treatment (radiation or surgery) at least one month ago, are not on steroids, and have been stable with no symptoms since then.
  • Side effects from any previous chemotherapy or radiation have mostly resolved, and any surgical wounds have healed.
  • You are in good enough general health to carry out daily activities with little or no limitation (confirm with trial site).
  • Your blood pressure is at or below 140/90 mmHg at the time of screening, with or without blood pressure medication, and your medication has not changed in the week before starting treatment.
  • Your kidneys are working well enough, based on a blood test result (confirm with trial site).
  • Your blood counts (white blood cells, red blood cells, and platelets) meet the minimum levels required by the study (confirm with trial site).
  • Your blood clotting is within an acceptable range, based on a standard blood test (confirm with trial site).
  • Your liver is functioning well enough, based on blood test results (confirm with trial site).
  • You are willing and able to give written consent and follow all parts of the study plan.

Who may not be able to join:

  • You have only differentiated thyroid cancer or medullary thyroid cancer, without an ATC component.
  • You are newly diagnosed and your doctors feel you are a good candidate for full combined treatment including surgery and/or radiation right now.
  • You have previously been treated with lenvatinib or similar targeted cancer drugs called tyrosine kinase inhibitors (TKIs), unless a low dose was used alongside radiation therapy specifically to make the radiation work better.
  • You had major surgery within the 2 weeks before starting the study drug.
  • You received any cancer treatment within 14 days, or any experimental treatment within 30 days, before starting the study drug.
  • You had radiation therapy within 3 weeks before starting the study drug.
  • You have too much protein in your urine, above the level allowed by the study (confirm with trial site).
  • You have had serious heart problems — such as severe heart failure, unstable chest pain, a heart attack, a stroke, or a significant abnormal heart rhythm — within the past 6 months.
  • You have a significant abnormality on a heart electrical test (ECG), including a specific measurement being too prolonged (confirm with trial site).
  • You currently have an active infection that requires treatment with antibiotics or other systemic medicines.
  • You have had significant coughing up of blood or tumor bleeding within the 2 weeks before starting the study drug.
  • Scans show that the cancer has grown into major blood vessels.
  • You have had another active cancer within the past 24 months, with some exceptions such as certain skin cancers or early-stage cervical or bladder cancer that have been fully treated.
  • You are scheduled to have major surgery during the study period.
  • You are pregnant or breastfeeding.
  • You are a woman who could become pregnant and are not willing or able to use a highly effective form of contraception during the study and for 30 days after finishing the study drug.
  • You have another serious ongoing illness (such as heart, lung, digestive, or kidney disease) that the study doctor believes could affect your safety or the study results.
  • You have a known allergy or intolerance to lenvatinib or any of its ingredients.
  • You have any other medical or personal condition that the study doctor believes would prevent you from safely participating.

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 22 July 2026
Phase 2: approximately ~30% 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

, Camperdown, New South Wales
, St Leonards, New South Wales

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
Terminated
Phase
Phase 2
Sponsor
Eisai Inc.
Registry
ClinicalTrials.gov
Start date
7 July 2016
Est. completion
26 September 2018

Where this trial is recruiting

🇦🇺 Australia 🇫🇷 France 🇮🇹 Italy 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Objective Response Rate (ORR)

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: 22 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