Actively Recruiting
Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)
Led by Washington University School of Medicine · Updated on 2026-03-17
34
Participants Needed
1
Research Sites
472 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This open-label, randomized phase II trial evaluates the dose delivery, tolerance, and efficacy of two dosing regimens of lenvatinib among patients with radioactive iodine resistant (RAIR) differentiated thyroid cancer (DTC).
CONDITIONS
Official Title
Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed differentiated thyroid cancer (papillary, follicular, or Hurthle Cell types)
- Incurable radioactive iodine resistant differentiated thyroid cancer defined by disease not curable by surgery and meeting one or more criteria: disease not taking up radioactive iodine, progression on radioactive iodine within last 12 months, cumulative radioactive iodine dose ≥ 600mCi, or ineligibility/decline of surgery and/or radioactive iodine
- Measurable or evaluable disease by RECIST 1.1 criteria
- No more than one prior VEGF/VEGFR targeted therapy for thyroid cancer
- Symptomatic or progressive disease on most recent prior treatment within last 16 months
- At least 18 years old
- ECOG performance status of 2 or less
- Screening blood pressure below 140/90 mmHg (retesting allowed)
- Adequate bone marrow and organ function including specific blood count, liver function, kidney function, and ECG criteria
- Agreement to use adequate contraception during study and for 30 days after last dose if of childbearing potential
- Ability and willingness to provide informed consent or have a legally authorized representative consent
You will not qualify if you...
- Anaplastic, poorly differentiated/high-grade, or medullary thyroid cancers
- Prior treatment with lenvatinib
- Prior or concurrent malignancies that interfere with safety or efficacy assessment
- Currently receiving other investigational agents
- Untreated brain metastases (treated brain metastases allowed if no progression on post-treatment imaging)
- Allergic reactions to lenvatinib or similar agents
- Use of medications with high risk for QTc prolongation without 7-day washout
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, or arrhythmia
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test
- Untreated or uncontrolled HIV, hepatitis B or C infections
- Major surgery within 14 days prior to first dose; wounds must be fully healed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
B
Brendan Knapp, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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