Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Lenvatinib (DTC Cohort); Lenvatinib (MTC Cohort)
Intervention description: 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily, or 10 mg lenvatinib orally twice daily (20 mg total). Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles.; 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily given continuously in 28-day treatment cycles.
Intervention MeSH terms: Lenvatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Thyroid Cancer

Summary:

      The purpose of this study is to determine the safety and efficacy of oral lenvatinib in
      participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant
      differentiated thyroid cancer (DTC), unresectable differentiated thyroid cancers, stratified
      by Histology.
    

Eligibility criteria:

        Inclusion criteria:

          1. Histologically or cytologically confirmed diagnosis of medullary thyroid cancer (MTC)
             or differentiated thyroid cancer (DTC).

          2. Measurable disease meeting the following criterion:

               1. At least one lesion (greater than or equal to 1.5 cm in longest diameter for
                  non-lymph nodes and greater than or equal to 2.0 cm in longest diameter for lymph
                  nodes) which is serially and accurately measurable according to modified response
                  evaluation criteria in solid tumours (RECIST) using either computed tomography
                  (CT) or magnetic resonance imaging (MRI).

               2. Lesions that have had electron beam radiotherapy must show evidence of
                  progressive disease based on modified RECIST to be deemed a target lesion.

          3. Evidence of disease progression by RECIST using site assessment of CT/MRI scans within
             12 months (+1 month to allow for variances in patient scanning intervals) prior to
             study entry.

          4. DTC must be 131-I refractory/resistant: never demonstrated 131-I uptake, progression
             despite 131-I uptake, or cumulative dose of 131-I of greater than 600 millicurie (mCi)
             (last dose given at least 6 months prior to study entry).

          5. Well controlled blood pressure prior to study entry.

        Exclusion criteria:

          1. Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid,
             metastases to the thyroid.

          2. Brain or leptomeningeal metastases.

          3. Significant cardiovascular impairment (history of congestive heart failure, New York
             Heart Association [NYHA] Class II, unstable angina or myocardial infarction within 6
             months of study start, or serious cardiac arrhythmia).

          4. Marked baseline prolongation of QT/corrected QT (QTc) interval.

          5. Proteinuria greater than 1+ or greater than 30 mg in dipstick testing.

          6. Active hemoptysis (bright red blood of at least one-half teaspoon) in the 28 days
             prior to study entry.