Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07092514
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cancer of the Thyroid
  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    Lenvatinib is an oral drug which will be administered on an outpatient basis at a dose of 24 mg daily or 10 mg daily for an unlimited number of cycles.

Study Details

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).

Key Dates

Start date
Oct 14, 2025
Status verified
Mar 2026
Primary completion
Apr 17, 2029
Completion
Oct 31, 2034

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1: Lenvatinib 10 mg/day
    Lenvatinib 10 mg per day. Each cycle is 28 days.
  • Experimental: Arm 2: Lenvatinib 24 mg/day
    Lenvatinib 24 mg per day. Each cycle is 28 days.

Primary Outcome Measure

Incidence rate of requiring a dose reduction of lenvatinib due to adverse event [ Time Frame: First 24 weeks of therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Brendan Knapp, M.D.
[email protected]
314-362-5485
Brendan Knapp, M.D. (PRINCIPAL_INVESTIGATOR)
Douglas Adkins, M.D. (SUB_INVESTIGATOR)
Jesse Zaretsky, M.D., Ph.D. (SUB_INVESTIGATOR)
Christine Auberle, M.D. (SUB_INVESTIGATOR)
Peter Oppelt, M.D. (SUB_INVESTIGATOR)
Sina Jasim, M.D. (SUB_INVESTIGATOR)
Esther Lu, Ph.D. (SUB_INVESTIGATOR)

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