Phase 2 Thyroid Cancer Trial, Recruiting NCT06458036 Sponsor: Children's Hospital of Philadelphia Condition: Thyroid Cancer
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Phase 2 Thyroid Cancer Trial, Recruiting

NCT06458036
Recruiting Phase 2

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 between 2 and 25 years old (inclusive)
  • You have been diagnosed with differentiated thyroid cancer, have had your thyroid removed, and have received appropriate treatment for any cancer spread to the lymph nodes in the neck
  • You have lung nodules (small spots on the lungs) visible on a CT scan — either more than 10 solid nodules, or any number of nodules that are growing and appear to be cancer that has spread
  • Your cancer has a specific change (called an "activating alteration") in a gene called RET, confirmed by a certified laboratory
  • You are able to carry out daily activities at a reasonable level (confirm with trial site)
  • Your blood counts are at acceptable levels — including white blood cells, platelets, and red blood cells
  • Your kidneys are working at an acceptable level
  • Your liver is working at an acceptable level, including acceptable levels of certain liver-related substances in your blood
  • Your blood levels of potassium, calcium, and magnesium are normal (supplements are allowed to help reach this)
  • If you are able to have children, you must agree to use highly effective birth control during treatment and for 6 months after the last dose
  • If you could become pregnant, you must have a negative pregnancy test within 24 hours before starting treatment, and at least once a month while on treatment

Who may not be able to join:

  • You have already had systemic (whole-body) treatment for thyroid cancer, including any RET-targeting drugs (note: previous radioactive iodine treatment is allowed)
  • You are currently pregnant or breastfeeding
  • You are currently taking certain medications that strongly affect how the body processes drugs (known as strong CYP3A4 inducers or inhibitors), or have taken them within 14 days before starting treatment (confirm specific medications with trial site)
  • You have significant heart problems, have had a heart attack in the last 6 months, or have an abnormal heart rhythm reading on an ECG (a heart tracing test) above a certain level
  • You have a condition that significantly affects your body's ability to absorb medicines taken by mouth
  • You are taking any medication known to affect heart rhythm in a specific way (QTc prolongation — confirm with trial site)
  • You have active bleeding or are at high risk of bleeding
  • You have uncontrolled high blood pressure (though blood pressure medication to help control it is allowed)

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 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

Principal Investigator: Theodore Laetsch, MD, Children's Hospital of Philadelphia

Phone: 267-426-9343

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
Recruiting
Phase
Phase 2
Sponsor
Children's Hospital of Philadelphia
Registry
ClinicalTrials.gov
Start date
29 July 2024
Est. completion
1 November 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of patients with complete overall, pulmonary, structural, and biochemical response.; Number of patients who survive without progression of disease after 5 years following protocol treatment.; Proportion of all patients enrolled who show increased radioactive iodine avidity at 6 months following selpercatinib monotherapy.; The incidence of adverse events and dose limiting toxicity with the combination of selpercatinib and 131I therapy, graded according to CTCAE v5.

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