Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
CompletedPhase 2Results postedLast updated 22 April 2020
What this trial tests
Phase 2 trial testing Lenvatinib (DTC Cohort) in Thyroid Cancer in 117 participants. Completed in 29 March 2019.
Adults 18 to 99, any sex, with Thyroid Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR)Primary· From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months
ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 for target lesions using magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent imaging review (IIR). CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. ORR=CR+PR, was presented with 2-sided 95% confid
Group
Value
95% CI
DTC Cohort
50.0
36.6 – 63.4
MTC Cohort
35.6
23.6 – 49.1
Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC)Primary· Cycle 1 Day 1 (predose and at 0.5 and 2 hours postdose), Cycle 1 Day 8 (predose), Cycle 2 Day 1 (predose and at 0.5 and 2 hours postdose), and Cycle 3 Day 1 (predose and at 2 hours postdose) (Cycle length= 28 days)
Up to 9 samples per participant were obtained at specific time points. Plasma concentrations of lenvatinib were analyzed using standard analysis methods. Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors for PK model development and covariate analysis. Individual exposure (steady state AUC) to lenvatinib in MTC and DTC subjects in this study was derived based on the individual predicted steady state AUC from the final PK model. Only data for participants taking 24 mg lenvatinib daily were reported
Group
Value
95% CI
DTC Cohort
3840
1610 – 6960
MTC Cohort
3350
1040 – 6840
Change From Baseline in Free Thyroxine (T4)Secondary· Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)
Blood samples to measure free T4 were collected at Screening (Baseline), Cycle 1 Day 15 (MTC cohort), Day 1 of Cycles 2 to 20, and Final Visit. Changes in free T4 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included.
Cycle 1 Day 15
Group
Value
95% CI
MTC Cohort
-3.80
Cycle 2 Day 1
Group
Value
95% CI
DTC Cohort
-0.46
± 5.149
MTC Cohort
-0.86
± 3.913
Cycle 3 Day 1
Group
Value
95% CI
DTC Cohort
-0.92
± 4.985
MTC Cohort
-1.00
± 4.028
Cycle 4 Day 1
Group
Value
95% CI
DTC Cohort
-1.05
± 5.581
MTC Cohort
0.34
± 4.192
Cycle 5 Day 1
Group
Value
95% CI
DTC Cohort
-1.03
± 5.563
MTC Cohort
-0.46
± 3.878
Cycle 6 Day 1
Group
Value
95% CI
DTC Cohort
-2.19
± 5.373
MTC Cohort
-0.17
± 4.719
Cycle 7 Day 1
Group
Value
95% CI
DTC Cohort
-2.32
± 5.098
MTC Cohort
-1.07
± 5.403
Cycle 8 Day 1
Group
Value
95% CI
DTC Cohort
-1.74
± 5.504
MTC Cohort
-1.13
± 5.691
Change From Baseline in Free Thyroid Stimulating Hormone (TSH)Secondary· Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)
Blood samples to measure free TSH were collected at Screening (Baseline), Cycle 1 Day 15 (MTC cohort), Day 1 of Cycles 2 to 20, and Final Visit. Changes in free TSH concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For any free TSH result that was reported as \<0.008 mIU/L, 0.004 mIU/L was used for calculating summary statistics.
Cycle 1 Day 15
Group
Value
95% CI
MTC Cohort
2.8030
Cycle 2 Day 1
Group
Value
95% CI
DTC Cohort
0.4779
± 3.07666
MTC Cohort
4.1585
± 7.34946
Cycle 3 Day 1
Group
Value
95% CI
DTC Cohort
0.5161
± 2.79122
MTC Cohort
5.5788
± 13.76600
Cycle 4 Day 1
Group
Value
95% CI
DTC Cohort
0.6296
± 2.29420
MTC Cohort
2.8751
± 6.50098
Cycle 5 Day 1
Group
Value
95% CI
DTC Cohort
0.5024
± 2.22721
MTC Cohort
3.7098
± 6.60386
Cycle 6 Day 1
Group
Value
95% CI
DTC Cohort
0.8603
± 3.09079
MTC Cohort
3.9822
± 10.65477
Cycle 7 Day 1
Group
Value
95% CI
DTC Cohort
0.6660
± 2.08608
MTC Cohort
8.4308
± 22.51715
Cycle 8 Day 1
Group
Value
95% CI
DTC Cohort
0.2118
± 3.16324
MTC Cohort
11.4131
± 32.65896
Percent Change From Baseline in Concentrations of Thyroglobulin (DTC Only)Secondary· Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 19, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)
Blood samples to obtain serum were collected at Cycle 1 Day 1 (Baseline), Day 1 of Cycles 2 to 19, Final Visit, and were analyzed for thyroglobulin concentration. Percent changes in thyroglobulin concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included.
Cycle 2 Day 1
Group
Value
95% CI
DTC Cohort
-62.21
± 39.997
Cycle 3 Day 1
Group
Value
95% CI
DTC Cohort
-77.80
± 22.278
Cycle 4 Day 1
Group
Value
95% CI
DTC Cohort
-79.25
± 26.639
Cycle 5 Day 1
Group
Value
95% CI
DTC Cohort
-76.00
± 25.085
Cycle 6 Day 1
Group
Value
95% CI
DTC Cohort
-20.36
± 373.190
Cycle 7 Day 1
Group
Value
95% CI
DTC Cohort
-73.38
± 45.489
Cycle 8 Day 1
Group
Value
95% CI
DTC Cohort
-79.96
± 27.461
Cycle 9 Day 1
Group
Value
95% CI
DTC Cohort
-73.98
± 31.366
Percent Change From Baseline in Concentrations of Calcitonin (MTC Only)Secondary· Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)
Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Day 1 of Cycles 2 to 20, Final Visit, and were analyzed for calcitonin concentration. Percent changes in calcitonin concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included.
Cycle 2 Day 1
Group
Value
95% CI
MTC Cohort
-42.27
± 38.754
Cycle 3 Day 1
Group
Value
95% CI
MTC Cohort
-48.11
± 30.976
Cycle 4 Day 1
Group
Value
95% CI
MTC Cohort
-44.54
± 38.794
Cycle 5 Day 1
Group
Value
95% CI
MTC Cohort
-49.97
± 34.634
Cycle 6 Day 1
Group
Value
95% CI
MTC Cohort
-41.73
± 46.653
Cycle 7 Day 1
Group
Value
95% CI
MTC Cohort
-38.18
± 62.721
Cycle 8 Day 1
Group
Value
95% CI
MTC Cohort
-47.29
± 46.101
Cycle 9 Day 1
Group
Value
95% CI
MTC Cohort
-37.52
± 72.588
Percent Change From Baseline in Concentrations of Carcinoembryonic Antigen (CEA) (MTC Only)Secondary· Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)
Blood samples were collected at Cycle 1 Day 1(Baseline), Day 1 of Cycles 2 to 20, Final Visit, and were analyzed for CEA concentration. Percent changes in CEA concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included.
Cycle 2 Day 1
Group
Value
95% CI
MTC Cohort
-26.07
± 45.864
Cycle 3 Day 1
Group
Value
95% CI
MTC Cohort
-37.68
± 42.236
Cycle 4 Day 1
Group
Value
95% CI
MTC Cohort
-41.49
± 48.035
Cycle 5 Day 1
Group
Value
95% CI
MTC Cohort
-44.62
± 42.138
Cycle 6 Day 1
Group
Value
95% CI
MTC Cohort
-41.91
± 47.388
Cycle 7 Day 1
Group
Value
95% CI
MTC Cohort
-41.39
± 45.677
Cycle 8 Day 1
Group
Value
95% CI
MTC Cohort
-42.89
± 47.818
Cycle 9 Day 1
Group
Value
95% CI
MTC Cohort
-49.31
± 32.185
Change From Baseline in Concentrations of Cytochrome C (CytoC)Secondary· Cycle 1 (Day 8), Cycle 2 (Days 1, 8 and 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1), and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)
Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Cycle 1 Day 8, Cycle 2 Days 1,8 \&15, Cycles 3 to 9,11,13 Day 1, Final Visit, and analyzed for CytoC concentration. Changes in CytoC concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For results reported as below quantifiable level (BQL), zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics.
Cycle 1 Day 8
Group
Value
95% CI
DTC Cohort
155.57
± 825.091
MTC Cohort
502.84
± 2146.291
Cycle 2 Day 1
Group
Value
95% CI
MTC Cohort
1679.40
Cycle 2 Day 8
Group
Value
95% CI
DTC Cohort
-218.45
± 591.217
MTC Cohort
374.46
± 2279.207
Cycle 2 Day 15
Group
Value
95% CI
DTC Cohort
-215.50
Cycle 3 Day 1
Group
Value
95% CI
DTC Cohort
-175.43
± 435.635
MTC Cohort
311.85
± 2363.970
Cycle 4 Day 1
Group
Value
95% CI
DTC Cohort
1.38
± 268.354
MTC Cohort
63.01
± 1738.149
Cycle 5 Day 1
Group
Value
95% CI
DTC Cohort
-21.32
± 85.469
MTC Cohort
1078.85
± 3793.235
Cycle 6 Day 1
Group
Value
95% CI
DTC Cohort
721.58
± 1234.215
MTC Cohort
1411.29
± 3855.502
Change From Baseline in Concentrations of M-30 Neo-AntigenSecondary· Cycle 1 (Day 8), Cycle 2 (Days 1, 8 & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11 & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)
Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Cycle 1 Day 8, Cycle 2 Days 1,8 \&15, Cycles 3 to 9,11,13 Day 1, Final Visit, and analyzed for M-30 concentration. Changes in M-30 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For results reported as BQL, zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics.
Cycle 1 Day 8
Group
Value
95% CI
DTC Cohort
-5.22
± 108.639
MTC Cohort
46.32
± 197.509
Cycle 2 Day 1
Group
Value
95% CI
MTC Cohort
-77.80
Cycle 2 Day 8
Group
Value
95% CI
DTC Cohort
-26.41
± 257.723
MTC Cohort
-49.33
± 289.525
Cycle 2 Day 15
Group
Value
95% CI
DTC Cohort
35.30
Cycle 3 Day 1
Group
Value
95% CI
DTC Cohort
19.70
± 296.010
MTC Cohort
-90.21
± 314.343
Cycle 4 Day 1
Group
Value
95% CI
DTC Cohort
-7.89
± 336.124
MTC Cohort
-97.53
± 296.832
Cycle 5 Day 1
Group
Value
95% CI
DTC Cohort
-24.83
± 397.337
MTC Cohort
-161.36
± 265.548
Cycle 6 Day 1
Group
Value
95% CI
DTC Cohort
-99.30
± 321.554
MTC Cohort
-161.30
± 214.299
Change From Baseline in Concentrations of Activated Caspase 3/7 (Casp 3/7)Secondary· Cycle 1 (Day 8), Cycle 2 (Days 1, 8, & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)
Blood samples to obtain serum were collected at Cycle 1 Day 1 (Baseline), Cycle 1 Day 8, Cycle 2 Days 1, 8, and 15, Cycles 3 to 9, 11, 13 (Day 1), Final Visit, and analyzed for Casp 3/7 concentration. Changes in Casp 3/7 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. The concentrations of Casp 3/7 were BQL for most participants at most time points. For results reported as BQL, zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only
Cycle 1 Day 8
Group
Value
95% CI
DTC Cohort
NA
± NA
MTC Cohort
0.0030
± 0.00610
Cycle 2 Day 1
Group
Value
95% CI
MTC Cohort
0.0080
Cycle 2 Day 8
Group
Value
95% CI
DTC Cohort
NA
± NA
MTC Cohort
0.0039
± 0.00822
Cycle 2 Day 15
Group
Value
95% CI
DTC Cohort
0.0110
Cycle 3 Day 1
Group
Value
95% CI
DTC Cohort
NA
± NA
MTC Cohort
0.0026
± 0.00691
Cycle 4 Day 1
Group
Value
95% CI
DTC Cohort
NA
± NA
MTC Cohort
0.0019
± 0.00743
Cycle 5 Day 1
Group
Value
95% CI
DTC Cohort
NA
± NA
MTC Cohort
0.0042
± 0.00666
Cycle 6 Day 1
Group
Value
95% CI
DTC Cohort
0.0046
± 0.00605
MTC Cohort
NA
± NA
Duration of Response (DoR) Assessed as Per Independent Imaging Reviewers (IIR)Secondary· From date of the first CR or PR until the date of first documentation of disease progression or date of death, assessed up to data cutoff date 11 April 2011
DoR was based on IIR was the time from date of the first CR or PR until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, for the participants who had BOR of CR or PR. Participants without progressive disease or death were censored at the date of last adequate tumor assessment. Duration of response = End Date - Date of first CR or PR + 1
Group
Value
95% CI
DTC Cohort
12.7
8.8 – NA
MTC Cohort
NA
5.7 – NA
Disease Control Rate (DCR) Assessed as Per IIRSecondary· From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months
DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks, based on assessments by IIR. DCR = CR+PR+SD greater than or equal to 7 weeks
Group
Value
95% CI
DTC Cohort
93.1
83.3 – 98.1
MTC Cohort
79.7
67.2 – 89.0
Adverse events — posted to ClinicalTrials.gov
Time frame: For each participant, from the first dose till 30 days after the last dose of study treatment (up to approximately 10 years 4 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
DTC Cohort
Serious: 32/58 (55%)
Deaths: 44/58
MTC Cohort
Serious: 42/59 (71%)
Deaths: 37/59
Serious adverse events (129 terms)
Reaction
System
DTC Cohort
MTC Cohort
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Pneumonia
Infections and infestations
—
—
Hypotension
Vascular disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
Lung infection
Infections and infestations
—
—
Amenorrhoea
Reproductive system and breast disorders
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Abdominal pain lower
Gastrointestinal disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Dysphagia
Gastrointestinal disorders
—
—
Pancreatitis
Gastrointestinal disorders
—
—
Pneumonia staphylococcal
Infections and infestations
—
—
Hypertension
Vascular disorders
—
—
Bradycardia
Cardiac disorders
—
—
Renal failure
Renal and urinary disorders
—
—
Asthenia
General disorders
—
—
Premature menopause
Reproductive system and breast disorders
—
—
Aspiration
Respiratory, thoracic and mediastinal disorders
—
—
Epistaxis
Respiratory, thoracic and mediastinal disorders
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
—
—
Oesophagobronchial fistula
Respiratory, thoracic and mediastinal disorders
—
—
Other adverse events (191 terms — click to expand)
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.
Publications & conference data
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 22 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00784303.