20 and older, 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.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)Primary· Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years
Only TEAEs are included in the summary. For detailed list of adverse events (AEs), see the AE section. For each participant, only one TEAE in the same category was counted and for multiple TEAEs with different Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) grades, only the event with the highest grade was reported. All AEs were graded using CTCAE v 4.0, except for alopecia and infertility.
TEAEs
Group
Value
95% CI
Arm 4: Lenvatinib (DTC, MTC, ATC)
100.0
CTCAE Grade 3 or 4 TEAEs
Group
Value
95% CI
Arm 4: Lenvatinib (DTC, MTC, ATC)
82.4
Serious TEAEs
Group
Value
95% CI
Arm 4: Lenvatinib (DTC, MTC, ATC)
52.9
TEAEs leading to study drug withdrawal
Group
Value
95% CI
Arm 4: Lenvatinib (DTC, MTC, ATC)
2.0
TEAEs leading to study drug reduction
Group
Value
95% CI
Arm 4: Lenvatinib (DTC, MTC, ATC)
96.1
TEAEs leading to study drug interruption
Group
Value
95% CI
Arm 4: Lenvatinib (DTC, MTC, ATC)
66.7
Progression-free Survival (PFS)Secondary· From first date of study treatment until progression of disease or date of death from any cause, whichever comes first, assessed up to 34 months
PFS was defined as the time from (1) the date of randomization to the date of first documentation of disease progression based on Investigator and Independent Review Committee assessments according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1), or (2) death, whichever came first. Disease progression for the MTC group was measured using computed tomography (CT) or magnetic resonance imaging (MRI) on targeted tumors. Disease progression per RECIST v1.1 was defined as at least a 20 percent (%) relative increase and 5 millimeter (mm) absolute increase in the sum of diam
Group
Value
95% CI
Lenvatinib (Arm 1)
25.8
18.4 – NA
Lenvatinib (Arm 2)
9.2
1.8 – NA
Lenvatinib (Arm 3)
7.4
1.7 – 12.9
Overall Survival (OS)Secondary· From study start until date of death from any cause, assessed up to 34 months
OS was defined as the time from the date of first dose of study treatment to the date of death from any cause. If death was not observed for a participant, the survival time was censored at the date the participant was last known alive or the data cutoff date (whichever occurred first). Summarized by the Kaplan-Meier method using median time with 95% CI.
Group
Value
95% CI
Lenvatinib (Arm 1)
31.8
31.8 – NA
Lenvatinib (Arm 2)
12.1
3.8 – NA
Lenvatinib (Arm 3)
10.6
3.8 – 19.8
Best Overall Response (BOR)Secondary· Date of first dose of study treatment to CR, PR, SD, PD, or NE, assessed up to 34 months
BOR was defined as the best response observed between the time of first dose and the study completion, assessed by either of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). Tumor assessment was performed by the investigator using RECIST 1.1. The CR and PR were determined only when these responses met each criterion even after 28 days from the time observed. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm.
CR
Group
Value
95% CI
Lenvatinib (Arm 1)
0
Lenvatinib (Arm 2)
0
Lenvatinib (Arm 3)
0
PR
Group
Value
95% CI
Lenvatinib (Arm 1)
68.0
Lenvatinib (Arm 2)
22.2
Lenvatinib (Arm 3)
23.5
SD
Group
Value
95% CI
Lenvatinib (Arm 1)
32.0
Lenvatinib (Arm 2)
77.8
Lenvatinib (Arm 3)
70.6
PD
Group
Value
95% CI
Lenvatinib (Arm 1)
0
Lenvatinib (Arm 2)
0
Lenvatinib (Arm 3)
5.9
NE
Group
Value
95% CI
Lenvatinib (Arm 1)
0
Lenvatinib (Arm 2)
0
Lenvatinib (Arm 3)
0
Objective Response Rate (ORR)Secondary· Date of CR or PR to date of PD or death (whichever was first), assessed up to 34 months
ORR was defined as the percentage of participants who had BOR of CR or PR. Tumor assessment was performed by the investigator using RECIST 1.1. ORR based on the investigator assessment was provided with a corresponding exact 95% CI which was calculated using exact method of binomial distribution.
Group
Value
95% CI
Lenvatinib (Arm 1)
68.0
46.5 – 85.1
Lenvatinib (Arm 2)
22.2
2.8 – 60.0
Lenvatinib (Arm 3)
23.5
6.8 – 49.9
Disease Control Rate (DCR)Secondary· Date of CR, PR, or SD to date of PD or death (whichever was first), assessed up to 34 months
The DCR was defined as the percentage of participants who had BOR of CR, PR, or SD. Tumor assessment was performed by the investigator using RECIST 1.1. DCR based on the investigator assessment was provided with a corresponding exact 95% CI which was calculated using exact method of binomial distribution.
Group
Value
95% CI
Lenvatinib (Arm 1)
100.0
86.3 – 100.0
Lenvatinib (Arm 2)
100.0
66.4 – 100.0
Lenvatinib (Arm 3)
94.1
71.3 – 99.9
Clinical Benefit Rate (CBR)Secondary· Date of CR, PR, or dSD to date of PD or death (whichever was first), assessed up to 34 months
The CBR was defined as the percentage of participants who had BOR of CR, PR, or durable SD (dSD). Tumor assessment was performed by the investigator using RECIST 1.1. Durable stable disease was defined as SD lasting greater than or equal to 23 weeks for DTC and MTC, greater than or equal to 11 weeks for ATC. A 95% CI was calculated using exact method of binomial distribution.
Group
Value
95% CI
Lenvatinib (Arm 1)
84.0
63.9 – 95.5
Lenvatinib (Arm 2)
77.8
40.0 – 97.2
Lenvatinib (Arm 3)
70.6
44.0 – 89.7
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs were collected for up to 3 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm 4: Lenvatinib (DTC, MTC, ATC)
Serious: 27/51 (53%)
Deaths: 4/51
Serious adverse events (30 terms)
Reaction
System
Arm 4: Lenvatinib (DTC, MT…
Decreased appetite
Metabolism and nutrition disorders
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Pneumonia
Infections and infestations
—
Nausea
Gastrointestinal disorders
—
Laryngeal stenosis
Respiratory, thoracic and mediastinal disorders
—
Diarrhoea
Gastrointestinal disorders
—
Dysphagia
Gastrointestinal disorders
—
Gastric ulcer
Gastrointestinal disorders
—
Haemorrhoidal haemorrhage
Gastrointestinal disorders
—
Fatigue
General disorders
—
Oedema peripheral
General disorders
—
Cholecystitis
Hepatobiliary disorders
—
Hepatic failure
Hepatobiliary disorders
—
Cellulitis
Infections and infestations
—
Diverticulitis
Infections and infestations
—
Gastroenteritis
Infections and infestations
—
Lung infection
Infections and infestations
—
Respiratory tract infection
Infections and infestations
—
Sepsis
Infections and infestations
—
Upper limb fracture
Injury, poisoning and procedural complications
—
Hypoglycaemia
Metabolism and nutrition disorders
—
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Vagus nerve disorder
Nervous system disorders
—
Other adverse events (68 terms — click to expand)
Reaction
System
Arm 4: Lenvatinib (DTC, MT…
Hypertension
Vascular disorders
—
Decreased appetite
Metabolism and nutrition disorders
—
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
—
Fatigue
General disorders
—
Proteinuria
Renal and urinary disorders
—
Stomatitis
Gastrointestinal disorders
—
Diarrhoea
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Dysphonia
Respiratory, thoracic and mediastinal disorders
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
Weight decreased
Investigations
—
Oedema peripheral
General disorders
—
Nasopharyngitis
Infections and infestations
—
Constipation
Gastrointestinal disorders
—
Headache
Nervous system disorders
—
Abdominal pain upper
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Myalgia
Musculoskeletal and connective tissue disorders
—
Thrombocytopenia
Blood and lymphatic system disorders
—
Epistaxis
Respiratory, thoracic and mediastinal disorders
—
Alopecia
Skin and subcutaneous tissue disorders
—
Rash
Skin and subcutaneous tissue disorders
—
Insomnia
Psychiatric disorders
—
Dermatitis acneiform
Skin and subcutaneous tissue disorders
—
Cough
Respiratory, thoracic and mediastinal disorders
—
Hypothyroidism
Endocrine disorders
—
Malaise
General disorders
—
Hypocalcaemia
Metabolism and nutrition disorders
—
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally administered once daily (QD) in subjects with advanced thyroid cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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 Co., Ltd.
Last refreshed: 14 August 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/NCT01728623.