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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02702388




Registration number
NCT02702388
Ethics application status
Date submitted
3/03/2016
Date registered
8/03/2016
Date last updated
24/11/2021

Titles & IDs
Public title
A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile
Scientific title
A Multicenter, Randomized, Double-Blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With 131I-Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 mg Daily Will Provide Comparable Efficacy to a 24-mg Starting Dose, But Have a Better Safety Profile
Secondary ID [1] 0 0
2014-005199-27
Secondary ID [2] 0 0
E7080-G000-211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Thyroid
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenvatinib
Treatment: Drugs - Lenvatinib matching placebo

Experimental: 24 mg Lenvatinib - Participants will receive 24 mg once daily (QD) as the starting dose. Dose reductions will occur in succession based on the previous dose level (24, 20, 14, 10, or 8 mg QD). To maintain blinded treatment assignment, participants will be administered study drug in the form of two 10-mg capsules and two 4-mg capsules containing either lenvatinib or placebo (total of 4 capsules) to be taken orally, at approximately the same time each morning and may be taken in a fasting state or following a meal.

Experimental: 18 mg Lenvatinib - Participants will receive 18mg QD as the starting dose. Dose reductions will occur in succession based on the previous dose level (18,14, 10, 8, or 4 mg QD). To maintain blinded treatment assignment, participants will be administered study drug in the form of two 10-mg capsules and two 4-mg capsules containing either lenvatinib or placebo (total of 4 capsules) to be taken orally, at approximately the same time each morning and may be taken in a fasting state or following a meal.


Treatment: Drugs: Lenvatinib
Lenvatinib capsule.

Treatment: Drugs: Lenvatinib matching placebo
Lenvatinib matching placebo capsule.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) as of Week 24 (ORR24wk)
Timepoint [1] 0 0
From the date of randomization up to Week 24
Primary outcome [2] 0 0
Percentage of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) in the First 24 Weeks
Timepoint [2] 0 0
Baseline up to Week 24
Secondary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Time from the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 2 years 6 months
Secondary outcome [2] 0 0
PFS After Next Line of Treatment (PFS2)
Timepoint [2] 0 0
Time from randomization to PD on next-line treatment or death from any cause, whichever occurs first up to approximately 2 years 6 months
Secondary outcome [3] 0 0
Number of Participants With TEAE and Serious Adverse Events (SAEs)
Timepoint [3] 0 0
From date of first administration of study drug up to 28 days after last dose of study drug up to approximately 3 years 3 months
Secondary outcome [4] 0 0
Time to Treatment Discontinuation Due to an Adverse Event (AE)
Timepoint [4] 0 0
From date of first administration of study drug up to approximately 2 years 6 months
Secondary outcome [5] 0 0
Number of Dose Reductions
Timepoint [5] 0 0
From date of first administration of study drug up to approximately 2 years 6 months
Secondary outcome [6] 0 0
Time to First Dose Reduction
Timepoint [6] 0 0
From date of first administration of study drug up to approximately 2 years 6 months
Secondary outcome [7] 0 0
Model Predicted Apparent Total Clearance (CL/F) Following Oral Dosing of Lenvatinib
Timepoint [7] 0 0
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days)
Secondary outcome [8] 0 0
Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib
Timepoint [8] 0 0
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days)
Secondary outcome [9] 0 0
Parameter Estimates From the Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model Describing the Relationship Between Lenvatinib Exposure (AUC) and Thyroglobulin Levels
Timepoint [9] 0 0
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days)
Secondary outcome [10] 0 0
Parameter Estimates From the Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model Describing the Relationship Between Lenvatinib Exposure (AUC) and Thyroid-Stimulating Hormone (TSH) Levels
Timepoint [10] 0 0
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days)
Secondary outcome [11] 0 0
Baseline Level Estimates From the Population PK/PD Model Describing the Relationship Between Lenvatinib Exposure (AUC) and Vascular Endothelial Growth Factor (VEGF), Soluble Tie-2, Angiopoietin-2 (Ang-2) and Fibroblast Growth Factor-23 (FGF23) Levels
Timepoint [11] 0 0
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days)
Secondary outcome [12] 0 0
Mean Residence Time (MRT) Estimates From the Population PK/PD Model Describing the Relationship Between Lenvatinib Exposure (AUC) and VEGF, Soluble Tie-2, Ang-2 and FGF23 Levels
Timepoint [12] 0 0
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days)
Secondary outcome [13] 0 0
Hill Coefficient Estimates From the Population PK/PD Model Describing the Relationship Between Lenvatinib Exposure (AUC) and VEGF, Soluble Tie-2, Ang-2 and FGF23 Levels
Timepoint [13] 0 0
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days)
Secondary outcome [14] 0 0
Parameter Estimates From the PK/PD Model for Tumor Growth Inhibition and Serum Biomarkers Tie-2 and Ang-2
Timepoint [14] 0 0
Baseline up to week 120
Secondary outcome [15] 0 0
Lenvatinib Mean AUC Resulting in 50% of the Emax (EC50) Estimate From the PK/PD Model for Tumor Growth Inhibition and Serum Biomarkers Tie-2 and Ang-2
Timepoint [15] 0 0
Baseline up to week 120
Secondary outcome [16] 0 0
Scale Factor Estimate for Final Parametric Time to Event PK/PD Model for PFS
Timepoint [16] 0 0
Time from the date of randomization to the date of first documentation of PD, or date of death, whichever occurred first up to approximately 3 years 3 months
Secondary outcome [17] 0 0
Shape Factor Estimate for Final Parametric Time to Event PK/PD Model for PFS
Timepoint [17] 0 0
Time from the date of randomization to the date of first documentation of PD, or date of death, whichever occurred first up to approximately 3 years 3 months
Secondary outcome [18] 0 0
Lenvatinib AUC Exposure Effect Estimate for Final Parametric Time to Event PK/PD Model for PFS
Timepoint [18] 0 0
Time from the date of randomization to the date of first documentation of PD, or date of death, whichever occurred first up to approximately 3 years 3 months
Secondary outcome [19] 0 0
Predicted Percent Change in Tumor Size Estimate for Final Parametric Time to Event PK/PD Model for PFS
Timepoint [19] 0 0
Time from the date of randomization to the date of first documentation of PD, or date of death, whichever occurred first up to approximately 3 years 3 months
Secondary outcome [20] 0 0
Baseline Tumor Size Estimate for Final Parametric Time to Event PK/PD Model for PFS
Timepoint [20] 0 0
Time from the date of randomization to the date of first documentation of PD, or date of death, whichever occurred first up to approximately 3 years 3 months
Secondary outcome [21] 0 0
Input Rate Indirect Effect Model Estimate From Base/Final PK/PD Blood Pressure Model
Timepoint [21] 0 0
From date of first administration of study drug up to 6 months
Secondary outcome [22] 0 0
Drug Effect on Systolic and Diastolic Input Rate Estimates From Base/Final PK/PD Blood Pressure Model
Timepoint [22] 0 0
From date of first administration of study drug up to 6 months
Secondary outcome [23] 0 0
Number of Participants With Weight Decrease Stratified by AUC Quartile (Q) Group
Timepoint [23] 0 0
Up to 3 years 3 months
Secondary outcome [24] 0 0
Number of Participants With Hypertension Stratified by AUC Quartile (Q) Group
Timepoint [24] 0 0
Up to 3 years 3 months
Secondary outcome [25] 0 0
Number of Participants With Proteinuria Stratified by AUC Quartile (Q) Group
Timepoint [25] 0 0
Up to 3 years 3 months
Secondary outcome [26] 0 0
Number of Participants With Fatigue Stratified by AUC Quartile (Q) Group
Timepoint [26] 0 0
Up to 3 years 3 months
Secondary outcome [27] 0 0
Number of Participants With Diarrhea Stratified by AUC Quartile (Q) Group
Timepoint [27] 0 0
Up to 3 years 3 months
Secondary outcome [28] 0 0
Number of Participants With Nausea Stratified by AUC Quartile (Q) Group
Timepoint [28] 0 0
Up to 3 years 3 months
Secondary outcome [29] 0 0
Number of Participants With Vomiting Stratified by AUC Quartile (Q) Group
Timepoint [29] 0 0
Up to 3 years 3 months
Secondary outcome [30] 0 0
Change From Baseline in the Health-Related Quality of Life (HRQoL) Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS)
Timepoint [30] 0 0
Baseline, Week 8, 16, and 24
Secondary outcome [31] 0 0
Change From Baseline in the HRQoL Assessed by Functional Assessment of Cancer Therapy-General (FACT-G) Total Score
Timepoint [31] 0 0
Baseline, Week 8, 16 and 24

Eligibility
Key inclusion criteria
1. Participants must have histologically or cytologically confirmed diagnosis of one of the following differentiated thyroid cancer (DTC) subtypes:

1. Papillary thyroid cancer (PTC)

* Follicular variant
* Variants (including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma, poorly differentiated)
2. Follicular thyroid cancer (FTC)

* Hurthle cell
* Clear cell
* Insular
2. Measurable disease meeting the following criteria and confirmed by central radiographic review:

1. At least 1 lesion of greater than or equal to (>=)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 that is serially measurable according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) using computed tomography/magnetic resonance imaging (CT/MRI). If there is only 1 target lesion and it is a non-lymph node, it should have a longest diameter of >=1.5 cm.
2. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
3. Participants must show evidence of disease progression within 12 months (an additional month will be allowed to accommodate actual dates of performance of screening scans, that is, within less than or equal to <=13 months) prior to signing informed consent, according to RECIST 1.1 assessed and confirmed by central radiographic review of CT and/or MRI scans.
4. Participants must be Iodine-131 refractory/resistant as defined by at least one of the following:

1. One or more measurable lesions that do not demonstrate iodine uptake on any radioiodine scan.
2. One or more measurable lesions that have progressed according to RECIST 1.1 within 12 months (an additional month will be allowed to accommodate actual dates of performance of screening scans, ie, within =13 months) after Iodine-131 therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre- or posttreatment scanning. These participants must not be eligible for possible curative surgery.
3. Cumulative activity of Iodine-131 of greater than (>) 600 millicurie (mCi) or 22 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry.
5. Participants with known brain metastases who have completed whole brain radiotherapy, stereotactic radiosurgery or complete surgical resection, will be eligible if they have remained clinically stable, asymptomatic, and off steroids for one month.
6. Participants must be receiving thyroxine suppression therapy and thyroid stimulating hormone (TSH) should not be elevated (TSH should be <=5.50 micro-international units per liter [mcIU/ML]). When tolerated by the participant, thyroxine dose should be changed to achieve TSH suppression (TSH <0.50 mcIU/ML) and this dose may be changed concurrently upon starting study drug treatment.
7. All chemotherapy or radiation-related toxicities must have resolved to Grade <2 severity per Common Terminology Criteria for Adverse Events (CTCAE v4.03), except alopecia and infertility.
8. Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
9. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP =150/90 mmHg at Screening and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1.
10. Adequate renal function defined as calculated creatinine clearance >=30 mL/min per the Cockcroft and Gault formula.
11. Adequate bone marrow function:

1. Absolute neutrophil count (ANC) >=1500/mm^3 (>=1.5*10^3/uL)
2. Platelets >=100,000/mm^3 (>=100*10^9/L)
3. Hemoglobin >=9.0 g/dL
12. Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) <=1.5.
13. Adequate liver function:

1. Bilirubin <=1.5*upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome.
2. Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3*ULN (<=5*ULN if participant has liver metastases). If alkaline phosphatase is >3*ULN (in absence of liver metastases) or >5*ULN (in presence of liver metastases) AND the participant also is known to have bone metastases, the liver-specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of total alkaline phosphatase.
14. Males or females age >=18 years at the time of informed consent.
15. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
16. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least 1 month before dosing).
17. Females of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment with lenvatinib and for at least 1 month after finishing treatment. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (example, total abstinence, an intrauterine device, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation. Women using oral hormonal contraceptives should add a barrier method.
18. Participants must voluntarily agree to provide written informed consent.
19. Participants must be willing and able to comply with all aspects of the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Anaplastic or medullary carcinoma of the thyroid.
2. Diagnosed with meningeal carcinomatosis.
3. Two or more prior vascular endothelial growth factor (VEGF)/vascular endothelial growth factor receptor (VEGFR)-targeted therapies or any ongoing treatment for RR-DTC other than TSH-suppressive thyroid hormone therapy.
4. Prior treatment with lenvatinib.
5. Participants who have received any anticancer treatment within 21 days or any investigational agent within 30 days (or 5 half-lives) prior to the first dose of study drug and should have recovered from any toxicity related to previous anticancer treatment. This does not apply to the use of TSH suppressive thyroid hormone therapy.
6. Major surgery (example, laparotomy, thoracotomy or joint replacement) within 3 weeks prior to randomization or elective surgery scheduled to be performed during the study.
7. Participants having >1+ proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein >=1 g/24 h will be ineligible.
8. Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of study drug.
9. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebral vascular accident within 6 months of the first dose of study drug, or cardiac arrhythmia associated with hemodynamic instability.
10. Prolongation of corrected QT interval (QTc) to >480 ms as demonstrated by a repeated electrocardiogram (ECG) or a clinically significant ECG abnormality, including a marked prolonged QT/QTc interval (example, a repeated demonstration of a QTc interval >500 ms).
11. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
12. Active infection (any infection requiring treatment).
13. Active malignancy (except for DTC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months.
14. Bleeding or thrombotic disorders.
15. Known intolerance to study drug (or any of the excipients).
16. Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.
17. Females who are pregnant or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/09/2020
Sample size
Target
Accrual to date
Final
241
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Facility #1 - Darlinghurst
Recruitment hospital [2] 0 0
Facility #1 - Saint Leonards
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [4] 0 0
Facility#2 - Chermside
Recruitment hospital [5] 0 0
Facility #1 - Herston
Recruitment hospital [6] 0 0
Facility #1 - Melbourne
Recruitment hospital [7] 0 0
Facility #1 - Nedlands
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Saint Leonards
Recruitment postcode(s) [3] 0 0
4006 - Brisbane
Recruitment postcode(s) [4] 0 0
- Chermside
Recruitment postcode(s) [5] 0 0
- Herston
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Belgium
State/province [11] 0 0
Antwerpen
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Belgium
State/province [13] 0 0
Namur
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Denmark
State/province [17] 0 0
Syddanmark
Country [18] 0 0
France
State/province [18] 0 0
Bas-Rhin
Country [19] 0 0
France
State/province [19] 0 0
Calvados
Country [20] 0 0
France
State/province [20] 0 0
Cote-d'Or
Country [21] 0 0
France
State/province [21] 0 0
Gironde
Country [22] 0 0
France
State/province [22] 0 0
Maine-et-Loire
Country [23] 0 0
France
State/province [23] 0 0
Val-de-Marne
Country [24] 0 0
France
State/province [24] 0 0
Angers
Country [25] 0 0
France
State/province [25] 0 0
Bordeaux
Country [26] 0 0
France
State/province [26] 0 0
Caen
Country [27] 0 0
France
State/province [27] 0 0
Dijon
Country [28] 0 0
France
State/province [28] 0 0
Lyon
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
Germany
State/province [30] 0 0
Baden-Wurttemberg
Country [31] 0 0
Germany
State/province [31] 0 0
Bayern
Country [32] 0 0
Germany
State/province [32] 0 0
Niedersachsen
Country [33] 0 0
Germany
State/province [33] 0 0
Nordrhein-Westfalen
Country [34] 0 0
Germany
State/province [34] 0 0
Essen
Country [35] 0 0
Germany
State/province [35] 0 0
Leipzig
Country [36] 0 0
Israel
State/province [36] 0 0
Petach Tikva
Country [37] 0 0
Italy
State/province [37] 0 0
Lazio
Country [38] 0 0
Italy
State/province [38] 0 0
Lombardia
Country [39] 0 0
Italy
State/province [39] 0 0
Toscana
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Pisa
Country [42] 0 0
Italy
State/province [42] 0 0
Roma
Country [43] 0 0
Italy
State/province [43] 0 0
Rozzano
Country [44] 0 0
Italy
State/province [44] 0 0
Torino
Country [45] 0 0
Italy
State/province [45] 0 0
Viagrande
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Busan
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Goyang-si
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Seoul
Country [49] 0 0
Poland
State/province [49] 0 0
Kielce
Country [50] 0 0
Romania
State/province [50] 0 0
Cluj
Country [51] 0 0
Romania
State/province [51] 0 0
Bucharest
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Leningradskaya O
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Moscow
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Obninsk
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Saint Petersburg
Country [56] 0 0
Spain
State/province [56] 0 0
Cataluna
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid, Communidad Delaware
Country [58] 0 0
Spain
State/province [58] 0 0
Badalona
Country [59] 0 0
Spain
State/province [59] 0 0
Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Malaga
Country [62] 0 0
Sweden
State/province [62] 0 0
Goteborg
Country [63] 0 0
Sweden
State/province [63] 0 0
Lund
Country [64] 0 0
United Kingdom
State/province [64] 0 0
City Of London
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Glasgow City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.
Trial website
https://clinicaltrials.gov/study/NCT02702388
Trial related presentations / publications
Brose MS, Panaseykin Y, Konda B, de la Fouchardiere C, Hughes BGM, Gianoukakis AG, Joo Park Y, Romanov I, Krzyzanowska MK, Leboulleux S, Binder TA, Dutcus C, Xie R, Taylor MH. A Randomized Study of Lenvatinib 18 mg vs 24 mg in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer. J Clin Endocrinol Metab. 2022 Feb 17;107(3):776-787. doi: 10.1210/clinem/dgab731.
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02702388