CompletedPhase 4

A Study to Evaluate the Safety and Efficacy of Lenvatinib in Participants With Refractory Differentiated Thyroid Cancer

India50 participantsStarted 2018-04-01

Plain-language summary

The purpose of this study is to evaluate the safety of lenvatinib in participants with recurrent, metastatic radio-iodine refractory differentiated thyroid cancer (DTC).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males and females who are diagnosed with locally Recurrent or Metastatic, Progressive, Radioiodine Refractory DTC, Lenvatinib naive and able to provide written informed consent.
✓. 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).
✓. Measurable disease meeting the following criteria: i) At least 1 lesion \>= 1.0 centimeter (cm) in the longest diameter for a non-lymph node or \>= 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). ii) Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must have shown evidence of PD based on RECIST 1.1 to be deemed a target lesion.
✓. Evidence of disease progression within 12 months of screening scan.
✓. Require thyroxine suppression therapy and thyroid stimulating hormone (TSH) should not be elevated (TSH should be less than \[\<\] 4.0 milli-international units per liter \[mIU/L\]).
✓. Participant must be radioiodine-refractory or resistant within 12 months of radioiodine therapy and have one of the following:
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Based on following laboratory assessment:

Exclusion criteria

✕. Anaplastic or medullary carcinoma of the thyroid.
✕. Two or more prior vascular endothelial growth factor (VEGF)/vascular endothelial growth factor receptor (VEGFR)-targeted therapies or any ongoing treatment for iodine-131 (131I) refractory DTC other than TSH-suppressive thyroid hormone therapy.
✕. Blood pressure (BP) \>= 140 millimeter of mercury (mmHg) Systolic and \>= 90 mmHg Diastolic at screening with or without antihypertensive medications.
✕. Woman who are lactating or pregnant at screening or baseline.
✕. Participants 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).
✕. Gastrointestinal malabsorption or any other condition that in the opinion of the investigator affected the absorption of Lenvatinib.
✕. Participant has history of congestive heart failure with New York Heart Association (NYHA) Classification \> II, unstable angina, myocardial infarction, serious cardiac arrhythmia, or stroke within the past 6 months.
✕. Electrocardiogram (ECG) with QT interval (QTc) interval \>= 450 millisecond (msec). (According to Bazett's formula).

What they're measuring

Percentage of Participants with Grade 2 or Higher Treatment-emergent Adverse Events

Timeframe: Baseline up to Week 24

Number of Dose Reductions

Timeframe: Baseline up to Week 24

Median Time to First Dose Reduction

Timeframe: Baseline up to Week 24

Trial details

NCT IDNCT03573960

SponsorEisai Pharmaceuticals India Pvt. Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-04

View on ClinicalTrials.gov More Thyroid Neoplasms trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males and females who are diagnosed with locally Recurrent or Metastatic, Progressive, Radioiodine Refractory DTC, Lenvatinib naive and able to provide written informed consent.
✓. 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).
✓. Measurable disease meeting the following criteria: i) At least 1 lesion \>= 1.0 centimeter (cm) in the longest diameter for a non-lymph node or \>= 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). ii) Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must have shown evidence of PD based on RECIST 1.1 to be deemed a target lesion.
✓. Evidence of disease progression within 12 months of screening scan.
✓. Require thyroxine suppression therapy and thyroid stimulating hormone (TSH) should not be elevated (TSH should be less than \[\<\] 4.0 milli-international units per liter \[mIU/L\]).
✓. Participant must be radioiodine-refractory or resistant within 12 months of radioiodine therapy and have one of the following:
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Based on following laboratory assessment:

Exclusion criteria

✕. Anaplastic or medullary carcinoma of the thyroid.
✕. Two or more prior vascular endothelial growth factor (VEGF)/vascular endothelial growth factor receptor (VEGFR)-targeted therapies or any ongoing treatment for iodine-131 (131I) refractory DTC other than TSH-suppressive thyroid hormone therapy.
✕. Blood pressure (BP) \>= 140 millimeter of mercury (mmHg) Systolic and \>= 90 mmHg Diastolic at screening with or without antihypertensive medications.
✕. Woman who are lactating or pregnant at screening or baseline.
✕. Participants 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).
✕. Gastrointestinal malabsorption or any other condition that in the opinion of the investigator affected the absorption of Lenvatinib.
✕. Participant has history of congestive heart failure with New York Heart Association (NYHA) Classification \> II, unstable angina, myocardial infarction, serious cardiac arrhythmia, or stroke within the past 6 months.
✕. Electrocardiogram (ECG) with QT interval (QTc) interval \>= 450 millisecond (msec). (According to Bazett's formula).