Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

NCT ID: NCT00784303

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-06
• Study Completion Date: 2019-03-29

Brief 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.

Detailed Description

This study contained 3 Phases: the Pretreatment Phase, the Treatment Phase, and the Extension Phase. The Pretreatment Phase lasted no longer than 28 days. Informed consent was obtained and protocol eligibility and disease characteristics were established prior to treatment. The Treatment Phase consisted of a Treatment Period and a Follow-up Period. The Treatment Period of the Treatment Phase began at the time that the first participant began study drug administration and ended at the time when all participants enrolled completed 8 cycles of treatment or discontinued study treatment prior to the eighth cycle (ie, time of data cutoff for the primary study analysis [Primary Completion Date]). All participants then entered the Extension Phase. The Extension Phase consisted of a Treatment Period and a Follow-up Period. The Extension Phase began immediately after the Treatment Phase ended and included all participants that were either still receiving treatment or in follow-up. The time of data cutoff for the primary study analysis occurred when all subjects in the study completed 8 cycles of treatment or discontinued study treatment prior to the eighth cycle.

Conditions

Thyroid Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DTC cohort

This arm will enroll participants with radioiodine (131 I)-refractory/resistant differentiated thyroid cancer.

Group Type: EXPERIMENTAL

Lenvatinib (DTC Cohort)

Intervention Type: DRUG

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.

MTC cohort

This arm will enroll participants with medullary thyroid cancer.

Group Type: EXPERIMENTAL

Lenvatinib (MTC Cohort)

Intervention Type: DRUG

24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily given continuously in 28-day treatment cycles.

Interventions

Lenvatinib (DTC Cohort)

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.

Intervention Type: DRUG

Lenvatinib (MTC Cohort)

24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily given continuously in 28-day treatment cycles.

Intervention Type: DRUG

Other Intervention Names

E7080, LENVIMA; E7080, LENVIMA

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Little Rock, Arkansas, United States

Los Angeles, California, United States

Los Gatos, California, United States

Mission Viejo, California, United States

Santa Monica, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Orlando, Florida, United States

Tampa, Florida, United States

Roswell, Georgia, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Bethesda, Maryland, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Columbia, Missouri, United States

Jefferson City, Missouri, United States

Lebanon, New Hampshire, United States

Montclair, New Jersey, United States

Houston, Texas, United States

Long Beach, Washington, United States

Seattle, Washington, United States

Madison, Wisconsin, United States

St Leonards, New South Wales, Australia

Brisbane, , Australia

Melbourne, , Australia

Lyon, , France

Paris, , France

Reims, , France

Villejuif, , France

Ferrara, , Italy

Milan, , Italy

Naples, , Italy

Pisa, , Italy

Rome, , Italy

Siena, , Italy

Gliwice, , Poland

Poznan, , Poland

Cardiff, , United Kingdom

Glasgow, , United Kingdom

London, , United Kingdom

Sutton, , United Kingdom

Countries

United States; Australia; France; Italy; Poland; United Kingdom

Other Identifiers

E7080-G000-201

Identifier Type: -

Identifier Source: org_study_id