Health Condition 1: null- Thyroid Cancer
Conditions
Interventions
Intervention1: lenvatinib: 24 mg once daily Orally in 28-day cycle. Dose interruptions and incremental reductions in the dose (to 20 mg, 14 mg, 10 mg per day) because of toxic effects will be permitte
Sponsors
Eisai Pharmaceuticals India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and females, age Greater than or equal to 18 years who are diagnosed with locally Recurrent or Metastatic, Progressive, Radioiodine Refractory Differentiated Thyroid Cancer, Lenvatinib naive and able to provide written informed consent. 2.Histologically or cytologically confirmed diagnosis of one of the following DTC subtypes: Papillary thyroid cancer (PTC) (including the follicular variants and other variants), Follicular thyroid cancer (FTC) (including Hurthle cell, Clear cell and Insular subtypes) 3.Measurable disease meeting the following criteria: 1) At least 1 lesion Greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or Greater than or equal to 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI). 2) Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must have shown evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
Exclusion criteria
Exclusion criteria: 1.Anaplastic or medullary carcinoma of the thyroid 2.Two or more prior VEGF/VEGFR-targeted therapies or any ongoing treatment for 131I-refractory DTC other than TSH-suppressive thyroid hormone therapy 3.Blood pressure (BP) Greater than or equal to 140 mm Hg Systolic and Greater than or equal to 90 mm Hg Diastolic at screening with or without antihypertensive medications 4.Woman who are lactating or pregnant at screening or baseline 5.Subjects who received any anticancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug. (This does not apply to the use of TSH-suppressive thyroid hormone therapy.) 6.Gastrointestinal malabsorption or any other condition that in the opinion of the investigator affected the absorption of Lenvatinib 7.Patient has history of congestive heart failure with New York Heart Association (NYHA) Classification Greater than II, unstable angina, myocardial infarction, serious cardiac arrhythmia, or stroke within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety as measured by rate of TEAEs with CTCAE grades of 2 or higher within 24 weeks after enrollment in to the treatment. 1. Number of dose reductions 2. Median Time to first dose reduction (95 perecent CI) Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate at the end of 6thcycle.(Measured according to RECIST 1.1) 1.Evaluation of progression free survival (PFS) (Time from enrollment in to the treatment to first occurrence of disease progression or death, whichever occurs first) 2.Evaluation of other TEAEs below CTCAE version 4.03 grade 2 Timepoint: 6thcycle | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research, Ahmedabad
Outcome results
None listed