Lenvatinib for Radioactive Iodine Resistant Thyroid Cancer
This study is testing two different daily doses of lenvatinib (24 mg or 10 mg) for people with differentiated thyroid cancer (DTC) that has become resistant to radioactive iodine (RAIR). Lenvatinib is a targeted therapy that works by affecting certain pathways (RAF, VEGF, VEGFR) involved in cancer growth. The study wants to see how well patients tolerate each dose, specifically looking at how often a dose reduction is needed due to side effects during the first 24 weeks. You may be able to join if you are 18 or older, have confirmed DTC that cannot be cured by surgery, and your cancer is resistant to radioactive iodine. The study is currently unclear on its recruitment status.
- Study design
- This is an open-label, randomized Phase II study involving 34 participants. It compares two different doses of lenvatinib.
- What's involved
- You would take lenvatinib orally every day for an unlimited number of cycles. This would be done on an outpatient basis.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for side effects is measured during the first 24 weeks of therapy.
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NCT07092514
Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)
Recruiting
PHASE2Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~34 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:Lenvatinib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence rate of requiring a dose reduction of lenvatinib due to adverse event
Measured over First 24 weeks of therapy
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Brendan Knapp, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically confirmed DTC, defined as papillary, follicular, or Hurthle Cell thyroid cancer. Papillary has several sub-types such as tall-cell and columnar cell, which are all allowed.
Patient must have incurable RAIR DTC, defined as disease not amenable to cure by surgery AND meeting one or more of the following criteria:
one or more sites of disease that do not take up RAI.
disease progression on RAI (given within the last 12 months).
receipt of cumulative dose of RAI of ≥ 600mCi.
patient declines or is ineligible for surgery and/or RAI.
Measurable or evaluable disease per RECIST 1.1.
No more than 1 prior line of VEGF/VEGFR targeted therapy for DTC. Examples of VEGF/VEGFR therapies include sorafenib, pazopanib, vandetinib, axitinib, sunitinib, and cabozantinib, but others exist.
Symptomatic (defined by usual standard of care clinical criteria) or progressive disease on most recent prior treatment (ex: surgery, RAI, or TKI/targeted therapy) by RECIST 1.1 over the last 16 months.
At least 18 years of age.
ECOG performance status ≤ 2.
Screening blood pressure measurement \<140/90. Retesting is allowed.
Adequate bone marrow and organ function as defined below:
Absolute neutrophil count ≥ 1.0 K/cumm
Platelets ≥ 100 K/cumm
Hemoglobin ≥ 9.0 g/dL
Total bilirubin ≤ 1.5 x IULN
AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN (5.0 x IULN in the presence of hepatic metastases)
Creatinine clearance \> 30 mL/min by Cockcroft-Gault
UPC ≤ 1000 mg/G
QTcF \< 481 msec
The effects of lenvatinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose of lenvatinib. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Measurable or evaluable disease per RECIST 1.1.
Symptomatic (defined by usual standard of care clinical criteria) or progressive disease by RECIST 1.1 while on lenvatinib.
ECOG performance status ≤ 2.
Re-screening blood pressure measurement \<140/90.
Adequate bone marrow and organ function as defined below:
Absolute neutrophil count ≥ 1.0 K/cumm
Platelets ≥ 100 K/cumm
Hemoglobin ≥ 9.0 g/dL
Total bilirubin ≤ 1.5 x IULN
AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN (5.0 x IULN in the presence of hepatic metastases)
Creatinine clearance \> 30 mL/min by Cockcroft-Gault
UPC ≤ 1000 mg/G
QTcF \< 481 msec
The most recent dose level of lenvatinib must be 10 mg/day.
Exclusion
Anaplastic, poorly differentiated/high-grade, and medullary thyroid cancers.
Prior treatment with lenvatinib.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
Currently receiving any other investigational agents.
Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to lenvatinib or other agents used in the study.
Use of concurrent medications that have a high risk for QTc prolongation. A 7 day washout period of the high-risk medication is required prior to the first dose of Lenvatinib if a patient discontinues the high risk medication for trial enrollment.
Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 14 days of C1D1.
HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
Major surgery ≤ 14 days prior to C1D1; any surgical wound must be fully healed prior to C1D1.
Currently receiving any other investigational agents.
Patients with untreated brain metastases. Patients with treated brain metastases (including those who had intracranial progression while on Lenvatinib) are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.
Use of concurrent medications that have a high risk for QTc prolongation.
Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
Experienced a grade three or higher treatment related adverse event requiring a dose delay on the 10 mg/day lenvatinib cohort
Pregnant and/or breastfeeding.
What this trial measures
- Incidence rate of requiring a dose reduction of lenvatinib due to adverse eventFirst 24 weeks of therapy