Phase 3 Thyroid Cancer Trial, Active, Not Recruiting NCT04211337 Sponsor: Loxo Oncology, 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 (NCT04211337) compared two treatment groups in people with a specific type of cancer: 193 participants received selpercatinib (Group A) and 98 participants received either cabozantinib or vandetanib (Group B). The trial was primarily measuring how long participants went without their disease getting worse or dying — a timeframe called "progression-free survival." It also looked at a number of secondary measures, including how many participants' tumours shrank or disappeared, how long those responses lasted, and how long participants survived overall. The reported data shows that for the main measure — time without disease worsening — a final number was only reported for Group B (cabozantinib or vandetanib), at 16.76 months; the corresponding figure for Group A (selpercatinib) was listed as "NA," meaning a final result was not available at the time of reporting. For the secondary measures, the proportion of participants whose tumours shrank or disappeared was reported as 69.4% in Group A and 38.8% in Group B. The length of time those responses lasted was reported for Group B at 16.56 months, while Group A's figure was again listed as not available. A measure called "treatment failure-free survival" — essentially how long participants stayed on treatment without their disease worsening or stopping due to intolerability — was reported as 13.93 months for Group B, with Group A's figure not available. The reported data shows that figures for overall survival and a longer-term progression measure (PFS2) were not reported in the submitted results. 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, Active, Not Recruiting

NCT04211337
Active, Not Recruiting 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 are at least 18 years old (or as young as 12 in some locations if local health authorities allow it).
  • You have been diagnosed with a type of thyroid cancer called medullary thyroid cancer (MTC) that cannot be removed by surgery and has either spread or is advanced, and you have not previously been treated with a type of drug called a kinase inhibitor for this advanced or spread disease.
  • Your cancer has been shown to be growing on scans compared to a previous scan taken within the last 14 months, and you have measurable or identifiable cancer (though if your cancer can only be seen in bone, additional requirements apply — confirm with trial site).
  • Your cancer or a blood/DNA sample has tested positive for a specific change in a gene called RET, and enough tumor tissue is available for further testing.
  • Your general health and ability to carry out daily activities is rated at a certain level (scored 0, 1, or 2 on a standard medical scale — confirm with trial site).
  • Your blood tests show that your blood, liver, kidney, and electrolyte levels are within an acceptable range.
  • If you are able to have children, you agree to use a highly effective form of contraception during the trial and for 4 months after your last dose of the study drug.
  • You are able to swallow capsules.

Who may not be able to join:

  • Your cancer has a known genetic change other than RET (such as RAS, BRAF, or NTRK) that could stop the study drug from working.
  • You have cancer that has spread to the brain and is causing symptoms, has spread along the lining of the brain or spinal cord, or you have untreated pressure on your spinal cord.
  • You have significant heart problems, have had a heart attack in the last 6 months, have a history of a specific dangerous heart rhythm problem, or your heart's electrical activity (measured by an ECG) shows certain abnormal readings (confirm with trial site for specific values).
  • You have an active infection (bacterial, viral, or fungal) or another serious ongoing illness that is not under control.
  • You are actively bleeding or are at high risk of serious bleeding.
  • You have or have had another type of cancer, unless it was a certain type of skin cancer, a very early-stage cancer, or a cancer that was diagnosed more than 2 years ago and is no longer active (people with a related condition called MEN2-associated pheochromocytoma may still be eligible — confirm with trial site).

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 26 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

Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM, Eli Lilly and Company

Australian sites

Royal North Shore Hospital, St Leonards, New South Wales
The Alfred Hospital, Melbourne, Victoria
Peter MacCallum Cancer Centre, Melbourne, Victoria
Sir Charles Gairdner Hospital, Perth, Western Australia

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
Active, Not Recruiting
Phase
Phase 3
Sponsor
Loxo Oncology, Inc.
Registry
ClinicalTrials.gov
Start date
11 February 2020
Est. completion
22 May 2023

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)

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: 26 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