18 and older, any sex, with Solid Tumor or Lymphoma. 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.
Maximum Tolerated Dose (MTD)Primary· Cycle 1 (4 weeks)
The MTD was defined as the highest dose level at which no more than one out of six participants experienced dose-limiting toxicity (DLT). DLT was assessed during the first 4 weeks of therapy (Cycle 1) for dose escalation purposes. Participants enrolled into the MTD cohort were given the option to also participate in the food-effect pilot study. The food-effect pilot study was initiated once the MTD had been established.
Group
Value
95% CI
Lenvatinib
25
Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)Secondary· First date of study treatment to date of last dose of study treatment, up to approximately 13 years and 8 months
All AEs were graded on a 5-point scale according to the National Cancer Institute's Common Toxicity Criteria (NCI CTC) grading system, version 3.0. Safety was assessed using the occurrence of DLTs, AEs, SAEs, clinical laboratory test results, vital signs measurements, physical examination findings, and electrocardiograms (ECGs) readings. An AE was defined as any untoward medical occurrence in a participant administered lenvatinib and did not necessarily have a causal relationship to lenvatinib. An SAE was defined as any untoward medical occurrence which results in death, was life-threatening,
Adverse events
Group
Value
95% CI
Lenvatinib 0.2 mg
100.0
Lenvatinib 0.4 mg
100.0
Lenvatinib 0.8 mg
100.0
Lenvatinib 1.6 mg
100.0
Lenvatinib 3.2 mg
100.0
Lenvatinib 6.4 mg
100.0
Lenvatinib 12 mg
100.0
Lenvatinib 12.5 mg
100.0
Lenvatinib 16 mg
100.0
Lenvatinib 20 mg
100.0
Lenvatinib Fasted/Fed 25 mg
100.0
Lenvatinib Fed/Fasted 25 mg
100.0
Treatment-related adverse events
Group
Value
95% CI
Lenvatinib 0.2 mg
75.0
Lenvatinib 0.4 mg
75.0
Lenvatinib 0.8 mg
50.0
Lenvatinib 1.6 mg
66.7
Lenvatinib 3.2 mg
100.0
Lenvatinib 6.4 mg
100.0
Lenvatinib 12 mg
91.7
Lenvatinib 12.5 mg
100.0
Lenvatinib 16 mg
100.0
Lenvatinib 20 mg
100.0
Lenvatinib Fasted/Fed 25 mg
100.0
Lenvatinib Fed/Fasted 25 mg
100.0
Serious adverse events
Group
Value
95% CI
Lenvatinib 0.2 mg
50.0
Lenvatinib 0.4 mg
50.0
Lenvatinib 0.8 mg
25.0
Lenvatinib 1.6 mg
33.3
Lenvatinib 3.2 mg
0
Lenvatinib 6.4 mg
100.0
Lenvatinib 12 mg
41.7
Lenvatinib 12.5 mg
44.4
Lenvatinib 16 mg
33.3
Lenvatinib 20 mg
100.0
Lenvatinib Fasted/Fed 25 mg
33.3
Lenvatinib Fed/Fasted 25 mg
40.0
Treatment-related serious adverse events
Group
Value
95% CI
Lenvatinib 0.2 mg
25.0
Lenvatinib 0.4 mg
0
Lenvatinib 0.8 mg
25.0
Lenvatinib 1.6 mg
0
Lenvatinib 3.2 mg
0
Lenvatinib 6.4 mg
33.3
Lenvatinib 12 mg
8.3
Lenvatinib 12.5 mg
11.1
Lenvatinib 16 mg
33.3
Lenvatinib 20 mg
66.7
Lenvatinib Fasted/Fed 25 mg
16.7
Lenvatinib Fed/Fasted 25 mg
20.0
Dose-limiting Toxicities (DLTs)Secondary· Cycle 1 (4 weeks) of each dose level
A DLT was defined as any grade 3 or higher hematological or non-hematological toxicity directly related to lenvatinib, any repeated National Cancer Institute Common Toxicity Criteria (NCI CTC) grade 2 hematological or non-hematological toxicity considered to be directly related to lenvatinib and required dose reduction, or failure to administer greater than or equal to 75% of the planned dosage of lenvatinib during Cycle 1 as a result of treatment-related failure.
Febrile neutropenia
Group
Value
95% CI
Lenvatinib 0.2 mg
0
Lenvatinib 0.4 mg
0
Lenvatinib 0.8 mg
0
Lenvatinib 1.6 mg
0
Lenvatinib 3.2 mg
0
Lenvatinib 6.4 mg
1
Lenvatinib 12 mg
0
Lenvatinib 12.5 mg
0
Lenvatinib 16 mg
0
Lenvatinib 20 mg
0
Lenvatinib (MTD Cohort) 25 mg
0
Lenvatinib 32 mg
0
Proteinuria
Group
Value
95% CI
Lenvatinib 0.2 mg
0
Lenvatinib 0.4 mg
0
Lenvatinib 0.8 mg
0
Lenvatinib 1.6 mg
0
Lenvatinib 3.2 mg
0
Lenvatinib 6.4 mg
0
Lenvatinib 12 mg
0
Lenvatinib 12.5 mg
1
Lenvatinib 16 mg
0
Lenvatinib 20 mg
0
Lenvatinib (MTD Cohort) 25 mg
0
Lenvatinib 32 mg
2
Thrombocytopenia
Group
Value
95% CI
Lenvatinib 0.2 mg
0
Lenvatinib 0.4 mg
0
Lenvatinib 0.8 mg
0
Lenvatinib 1.6 mg
0
Lenvatinib 3.2 mg
0
Lenvatinib 6.4 mg
0
Lenvatinib 12 mg
0
Lenvatinib 12.5 mg
1
Lenvatinib 16 mg
0
Lenvatinib 20 mg
0
Lenvatinib (MTD Cohort) 25 mg
0
Lenvatinib 32 mg
0
Hypertension
Group
Value
95% CI
Lenvatinib 0.2 mg
0
Lenvatinib 0.4 mg
0
Lenvatinib 0.8 mg
0
Lenvatinib 1.6 mg
0
Lenvatinib 3.2 mg
0
Lenvatinib 6.4 mg
0
Lenvatinib 12 mg
0
Lenvatinib 12.5 mg
0
Lenvatinib 16 mg
1
Lenvatinib 20 mg
0
Lenvatinib (MTD Cohort) 25 mg
0
Lenvatinib 32 mg
0
Fatigue
Group
Value
95% CI
Lenvatinib 0.2 mg
0
Lenvatinib 0.4 mg
0
Lenvatinib 0.8 mg
0
Lenvatinib 1.6 mg
0
Lenvatinib 3.2 mg
0
Lenvatinib 6.4 mg
0
Lenvatinib 12 mg
0
Lenvatinib 12.5 mg
0
Lenvatinib 16 mg
1
Lenvatinib 20 mg
0
Lenvatinib (MTD Cohort) 25 mg
0
Lenvatinib 32 mg
0
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%Secondary· First date of study treatment to date of withdrawal from study or last dose of study treatment, up to approximately 13 years and 8 months
Treatment-related AEs were untoward medical events that were considered by the investigator to be possibly or probably related to lenvatinib.
Hypertension
Group
Value
95% CI
Lenvatinib 0.2 - 6.4 mg
10
Lenvatinib 12 - 20 mg
40
Lenvatinib 25 mg
63
Lenvatinib 32 mg
57
Nausea
Group
Value
95% CI
Lenvatinib 0.2 - 6.4 mg
38
Lenvatinib 12 - 20 mg
17
Lenvatinib 25 mg
58
Lenvatinib 32 mg
43
Diarrhoea
Group
Value
95% CI
Lenvatinib 0.2 - 6.4 mg
19
Lenvatinib 12 - 20 mg
27
Lenvatinib 25 mg
50
Lenvatinib 32 mg
57
Stomatitis
Group
Value
95% CI
Lenvatinib 0.2 - 6.4 mg
5
Lenvatinib 12 - 20 mg
20
Lenvatinib 25 mg
63
Lenvatinib 32 mg
57
Proteinuria
Group
Value
95% CI
Lenvatinib 0.2 - 6.4 mg
14
Lenvatinib 12 - 20 mg
27
Lenvatinib 25 mg
29
Lenvatinib 32 mg
43
Vomiting
Group
Value
95% CI
Lenvatinib 0.2 - 6.4 mg
33
Lenvatinib 12 - 20 mg
10
Lenvatinib 25 mg
33
Lenvatinib 32 mg
14
Lethargy
Group
Value
95% CI
Lenvatinib 0.2 - 6.4 mg
14
Lenvatinib 12 - 20 mg
17
Lenvatinib 25 mg
38
Lenvatinib 32 mg
29
Dysphonia
Group
Value
95% CI
Lenvatinib 0.2 - 6.4 mg
0
Lenvatinib 12 - 20 mg
13
Lenvatinib 25 mg
46
Lenvatinib 32 mg
43
Best Overall Response (BOR)Secondary· Baseline to first date of documented CR, PR, SD, or PD, assessed up to approximately 4 years
BOR was the best confirmed response of complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD), or not evaluable (NE), recorded from the start of lenvatinib until disease progression/recurrence or death. CR; disappearance of all target lesions for at least 1 month. PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD; a 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum longest diameter recorded since treatment started or th
Partial response
Group
Value
95% CI
Lenvatinib 0.2 mg
0
Lenvatinib 0.4 mg
0
Lenvatinib 0.8 mg
0
Lenvatinib 1.6 mg
0
Lenvatinib 3.2 mg
0
Lenvatinib 6.4 mg
0
Lenvatinib 12 mg
0
Lenvatinib 12.5 mg
11.1
Lenvatinib 16 mg
0
Lenvatinib 20 mg
33.3
Lenvatinib (MTD Cohort) 25 mg
12.5
Lenvatinib 32 mg
28.6
Stable disease
Group
Value
95% CI
Lenvatinib 0.2 mg
0
Lenvatinib 0.4 mg
0
Lenvatinib 0.8 mg
25.0
Lenvatinib 1.6 mg
33.3
Lenvatinib 3.2 mg
66.7
Lenvatinib 6.4 mg
0
Lenvatinib 12 mg
33.3
Lenvatinib 12.5 mg
55.6
Lenvatinib 16 mg
83.3
Lenvatinib 20 mg
33.3
Lenvatinib (MTD Cohort) 25 mg
66.7
Lenvatinib 32 mg
42.9
Progressive disease
Group
Value
95% CI
Lenvatinib 0.2 mg
50.0
Lenvatinib 0.4 mg
50.0
Lenvatinib 0.8 mg
0
Lenvatinib 1.6 mg
0
Lenvatinib 3.2 mg
0
Lenvatinib 6.4 mg
33.3
Lenvatinib 12 mg
41.7
Lenvatinib 12.5 mg
11.1
Lenvatinib 16 mg
16.7
Lenvatinib 20 mg
0
Lenvatinib (MTD Cohort) 25 mg
8.3
Lenvatinib 32 mg
0
Not evaluable
Group
Value
95% CI
Lenvatinib 0.2 mg
25.0
Lenvatinib 0.4 mg
0
Lenvatinib 0.8 mg
0
Lenvatinib 1.6 mg
0
Lenvatinib 3.2 mg
0
Lenvatinib 6.4 mg
0
Lenvatinib 12 mg
8.3
Lenvatinib 12.5 mg
0
Lenvatinib 16 mg
0
Lenvatinib 20 mg
0
Lenvatinib (MTD Cohort) 25 mg
0
Lenvatinib 32 mg
0
Maximum Plasma Concentration (Cmax) of LenvatinibSecondary· Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)
Cycle 1 Day 1
Group
Value
95% CI
Lenvatinib 0.2 mg
0.753
± 0.2176
Lenvatinib 0.4 mg
1.740
± 0.6921
Lenvatinib 0.8 mg
4.255
± 1.7474
Lenvatinib 1.6 mg
20.967
± 11.6741
Lenvatinib 3.2 mg
49.883
± 15.9952
Lenvatinib 6.4 mg
127.067
± 91.3320
Lenvatinib 12 mg
259.990
± 108.1789
Lenvatinib 12.5 mg
209.004
± 112.0090
Lenvatinib 16 mg
375.077
± 158.1811
Lenvatinib 20 mg
408.797
± 105.6923
Lenvatinib (MTD Cohort) 25 mg
630.589
± 234.1659
Lenvatinib 32 mg
649.927
± 237.7462
Cycle 2 Day 1
Group
Value
95% CI
Lenvatinib 0.2 mg
2.385
± 0.5162
Lenvatinib 0.4 mg
5.477
± 1.5988
Lenvatinib 0.8 mg
9.610
± 2.3193
Lenvatinib 1.6 mg
36.483
± 10.9339
Lenvatinib 3.2 mg
92.137
± 29.0365
Lenvatinib 6.4 mg
197.217
± 136.7307
Lenvatinib 12 mg
291.414
± 146.1972
Lenvatinib 12.5 mg
187.467
± 86.3962
Lenvatinib 16 mg
368.937
± 148.8160
Lenvatinib 20 mg
238.670
± NA
Lenvatinib (MTD Cohort) 25 mg
544.718
± 183.1259
Lenvatinib 32 mg
562.416
± 121.4056
Time to Maximum Plasma Concentration (Tmax) of LenvatinibSecondary· Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)
Cycle 1 Day 1
Group
Value
95% CI
Lenvatinib 0.2 mg
4.280
± 1.440
Lenvatinib 0.4 mg
5.785
± 2.569
Lenvatinib 0.8 mg
3.263
± 1.194
Lenvatinib 1.6 mg
3.973
± 3.494
Lenvatinib 3.2 mg
9.557
± 12.658
Lenvatinib 6.4 mg
2.023
± 1.035
Lenvatinib 12 mg
2.348
± 1.144
Lenvatinib 12.5 mg
1.897
± 0.7768
Lenvatinib 16 mg
2.287
± 0.3881
Lenvatinib 20 mg
2.533
± 0.826
Lenvatinib (MTD Cohort) 25 mg
1.770
± 0.715
Lenvatinib 32 mg
2.674
± 2.038
Cycle 2 Day 1
Group
Value
95% CI
Lenvatinib 0.2 mg
2.225
± 0.3889
Lenvatinib 0.4 mg
2.680
± 0.589
Lenvatinib 0.8 mg
13.475
± 14.814
Lenvatinib 1.6 mg
2.360
± 1.179
Lenvatinib 3.2 mg
2.173
± 0.583
Lenvatinib 6.4 mg
2.103
± 0.405
Lenvatinib 12 mg
2.021
± 1.295
Lenvatinib 12.5 mg
1.944
± 0.604
Lenvatinib 16 mg
2.352
± 0.705
Lenvatinib 20 mg
3.000
± NA
Lenvatinib (MTD Cohort) 25 mg
2.983
± 1.481
Lenvatinib 32 mg
1.500
± 0.408
Apparent Plasma Half-life (t1/2) of LenvatinibSecondary· Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)
Cycle 1 Day 1
Group
Value
95% CI
Lenvatinib 0.8 mg
18.180
± 11.342
Lenvatinib 1.6 mg
10.695
± 8.789
Lenvatinib 3.2 mg
12.805
± 3.118
Lenvatinib 6.4 mg
8.077
± 0.749
Lenvatinib 12 mg
5.981
± 0.4840
Lenvatinib 12.5 mg
6.567
± 0.9553
Lenvatinib 16 mg
7.115
± 1.0866
Lenvatinib 20 mg
6.960
± 1.230
Lenvatinib (MTD Cohort) 25 mg
5.848
± 1.018
Lenvatinib 32 mg
5.550
± 0.599
Cycle 2 Day 1
Group
Value
95% CI
Lenvatinib 0.2 mg
29.540
± 8.2731
Lenvatinib 0.4 mg
26.380
± 8.0427
Lenvatinib 0.8 mg
20.840
± NA
Lenvatinib 1.6 mg
10.827
± 5.555
Lenvatinib 3.2 mg
9.973
± 1.288
Lenvatinib 6.4 mg
8.330
± 0.517
Lenvatinib 12 mg
6.935
± 1.1681
Lenvatinib 12.5 mg
6.829
± 1.019
Lenvatinib 16 mg
6.935
± 0.9313
Lenvatinib 20 mg
8.090
± NA
Lenvatinib (MTD Cohort) 25 mg
6.025
± 0.704
Lenvatinib 32 mg
6.675
± 0.5216
Area Under the Plasma Concentration Curve From Time 0 to Infinity (AUC(0-inf))Secondary· Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)
Cycle 1 Day 1
Group
Value
95% CI
Lenvatinib 0.8 mg
123.745
± 20.810
Lenvatinib 1.6 mg
376.645
± 312.1240
Lenvatinib 3.2 mg
780.275
± 189.116
Lenvatinib 6.4 mg
1335.493
± 894.562
Lenvatinib 12 mg
1895.454
± 467.145
Lenvatinib 12.5 mg
1693.298
± 1011.7941
Lenvatinib 16 mg
3683.590
± 2210.4521
Lenvatinib 20 mg
4238.680
± 2602.9271
Lenvatinib (MTD Cohort) 25 mg
4413.263
± 1946.571
Lenvatinib 32 mg
4383.678
± 1697.248
Cycle 2 Day 1
Group
Value
95% CI
Lenvatinib 0.2 mg
99.325
± 0.1202
Lenvatinib 0.4 mg
174.310
± 46.259
Lenvatinib 0.8 mg
370.390
± NA
Lenvatinib 1.6 mg
585.247
± 397.909
Lenvatinib 3.2 mg
1150.393
± 192.365
Lenvatinib 6.4 mg
1952.430
± 1323.783
Lenvatinib 12 mg
2278.016
± 851.258
Lenvatinib 12.5 mg
1558.101
± 760.687
Lenvatinib 16 mg
3310.673
± 1544.708
Lenvatinib 20 mg
2260.040
± NA
Lenvatinib (MTD Cohort) 25 mg
4549.825
± 1161.045
Lenvatinib 32 mg
4391.160
± 997.486
Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC(0-24))Secondary· Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)
Cycle 1 Day 1
Group
Value
95% CI
Lenvatinib 0.2 mg
14.348
± 4.500
Lenvatinib 0.4 mg
30.207
± 14.521
Lenvatinib 0.8 mg
61.915
± 17.164
Lenvatinib 1.6 mg
220.910
± 129.838
Lenvatinib 3.2 mg
659.553
± 209.129
Lenvatinib 6.4 mg
1168.257
± 799.169
Lenvatinib 12 mg
1655.035
± 555.479
Lenvatinib 12.5 mg
1537.476
± 876.6805
Lenvatinib 16 mg
3250.843
± 1826.8789
Lenvatinib 20 mg
3709.550
± 2059.6379
Lenvatinib (MTD Cohort) 25 mg
4074.803
± 1666.2780
Lenvatinib 32 mg
4601.014
± 1887.3642
Cycle 2 Day 1
Group
Value
95% CI
Lenvatinib 0.2 mg
43.305
± 8.5913
Lenvatinib 0.4 mg
85.477
± 37.054
Lenvatinib 0.8 mg
199.100
± NA
Lenvatinib 1.6 mg
422.873
± 270.528
Lenvatinib 3.2 mg
931.307
± 179.514
Lenvatinib 6.4 mg
1691.160
± 1167.750
Lenvatinib 12 mg
2052.965
± 789.504
Lenvatinib 12.5 mg
1422.584
± 697.699
Lenvatinib 16 mg
2947.920
± 1286.805
Lenvatinib 20 mg
1934.500
± NA
Lenvatinib (MTD Cohort) 25 mg
4224.095
± 1120.837
Lenvatinib 32 mg
4020.185
± 899.182
Clearance Corrected for the Fraction of Lenvatinib Absorbed (CL/F)Secondary· Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)
Cycle 1 Day 1
Group
Value
95% CI
Lenvatinib 0.8 mg
6.560
± 1.103
Lenvatinib 1.6 mg
6.470
± 5.360
Lenvatinib 3.2 mg
4.225
± 1.0253
Lenvatinib 6.4 mg
8.190
± 7.923
Lenvatinib 12 mg
6.614
± 1.336
Lenvatinib 12.5 mg
9.534
± 4.307
Lenvatinib 16 mg
6.157
± 4.240
Lenvatinib 20 mg
5.980
± 3.236
Lenvatinib (MTD Cohort) 25 mg
6.863
± 3.354
Lenvatinib 32 mg
8.827
± 5.058
Cycle 2 Day 1
Group
Value
95% CI
Lenvatinib 0.2 mg
4.710
± 0.9334
Lenvatinib 0.4 mg
5.200
± 1.802
Lenvatinib 0.8 mg
4.020
± NA
Lenvatinib 1.6 mg
5.347
± 3.942
Lenvatinib 3.2 mg
3.533
± 0.747
Lenvatinib 6.4 mg
5.557
± 4.200
Lenvatinib 12 mg
6.896
± 3.360
Lenvatinib 12.5 mg
10.110
± 3.321
Lenvatinib 16 mg
6.437
± 3.668
Lenvatinib 20 mg
10.340
± NA
Lenvatinib (MTD Cohort) 25 mg
6.378
± 2.302
Lenvatinib 32 mg
7.978
± 2.763
Apparent Volume of Distribution (Vz/F)Secondary· Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)
Cycle 1 Day 1
Group
Value
95% CI
Lenvatinib 0.8 mg
162.975
± 78.383
Lenvatinib 1.6 mg
65.795
± 0.6435
Lenvatinib 3.2 mg
80.365
± 37.922
Lenvatinib 6.4 mg
97.190
± 95.442
Lenvatinib 12 mg
57.039
± 11.887
Lenvatinib 12.5 mg
88.069
± 38.174
Lenvatinib 16 mg
58.408
± 32.346
Lenvatinib 20 mg
56.350
± 22.932
Lenvatinib (MTD Cohort) 25 mg
55.263
± 22.411
Lenvatinib 32 mg
68.073
± 32.456
Cycle 2 Day 1
Group
Value
95% CI
Lenvatinib 0.2 mg
206.360
± 96.068
Lenvatinib 0.4 mg
208.937
± 114.969
Lenvatinib 0.8 mg
120.810
± NA
Lenvatinib 1.6 mg
65.437
± 24.894
Lenvatinib 3.2 mg
51.487
± 16.805
Lenvatinib 6.4 mg
67.747
± 51.897
Lenvatinib 12 mg
70.881
± 40.419
Lenvatinib 12.5 mg
99.960
± 37.787
Lenvatinib 16 mg
60.683
± 26.763
Lenvatinib 20 mg
120.730
± NA
Lenvatinib (MTD Cohort) 25 mg
57.143
± 28.550
Lenvatinib 32 mg
76.610
± 25.967
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events (AEs) were collected for up to approximately 13 years and 8 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Lenvatinib 0.2 mg
Serious: 2/4 (50%)
Deaths: 0/4
Lenvatinib 0.4 mg
Serious: 2/4 (50%)
Deaths: 1/4
Lenvatinib 0.8 mg
Serious: 1/4 (25%)
Deaths: 1/4
Lenvatinib 1.6 mg
Serious: 1/3 (33%)
Deaths: 1/3
Lenvatinib 3.2 mg
Serious: 0/3 (0%)
Deaths: 0/3
Lenvatinib 6.4 mg
Serious: 3/3 (100%)
Deaths: 2/3
Lenvatinib 12 mg
Serious: 5/12 (42%)
Deaths: 1/12
Lenvatinib 12.5 mg
Serious: 4/9 (44%)
Deaths: 1/9
Lenvatinib 16 mg
Serious: 2/6 (33%)
Deaths: 1/6
Lenvatinib 20 mg
Serious: 3/3 (100%)
Deaths: 3/3
Lenvatinib Fasted/Fed 25 mg
Serious: 2/6 (33%)
Deaths: 0/6
Lenvatinib Fed/Fasted 25 mg
Serious: 2/5 (40%)
Deaths: 0/5
Lenvatinib (MTD Cohort) 25 mg
Serious: 15/24 (63%)
Deaths: 3/24
Lenvatinib 32 mg
Serious: 3/7 (43%)
Deaths: 2/7
Serious adverse events (63 terms)
Reaction
System
Lenvatinib 0.2 mg
Lenvatinib 0.4 mg
Lenvatinib 0.8 mg
Lenvatinib 1.6 mg
Lenvatinib 3.2 mg
Lenvatinib 6.4 mg
Lenvatinib 12 mg
Lenvatinib 12.5 mg
Lenvatinib 16 mg
Lenvatinib 20 mg
Lenvatinib Fasted/Fed 25 mg
Lenvatinib Fed/Fasted 25 mg
Lenvatinib (MTD Cohort) 25…
Lenvatinib 32 mg
Abdominal pain
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Hypertension
Vascular disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
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Ileus
Gastrointestinal disorders
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Abdominal distension
Gastrointestinal disorders
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Ascites
Gastrointestinal disorders
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Constipation
Gastrointestinal disorders
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Duodenal obstruction
Gastrointestinal disorders
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Dysphagia
Gastrointestinal disorders
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Faecaloma
Gastrointestinal disorders
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Haematemesis
Gastrointestinal disorders
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Melaena
Gastrointestinal disorders
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Rectal haemorrhage
Gastrointestinal disorders
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Pyrexia
General disorders
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General physical health deterioration
General disorders
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Malaise
General disorders
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Performance status decreased
General disorders
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Lower respiratory tract infection
Infections and infestations
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Abscess
Infections and infestations
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Abscess limb
Infections and infestations
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Groin infection
Infections and infestations
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Other adverse events (213 terms — click to expand)
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer
· Phase 3
· not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence
· Phase 3
· not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin
· Phase 2
· not yet recruiting
NCT07493668 — Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy
· Phase 2
· not yet recruiting
Other Eisai Inc. trials
Trials by the same sponsor.
NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy
· Phase 2
· not yet recruiting
NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants
· Phase 1
· recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants
· Phase 1
· recruiting
NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P
· active not recruiting
NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease
· Phase 2
· active not recruiting
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 June 2023
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/NCT00121719.