Adults 18 to 99, any sex, with Thyroid Carcinoma, Anaplastic. 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 the date of beginning of lenvatinib administration to the date of first documentation of disease progression or death, whichever occurred first (up to Month 27)
ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target lesions. CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameters of target lesions, taking as reference the Baseline sum diameters.
Group
Value
95% CI
Lenvatinib 24 mg
3.0
0.1 – 15.8
Progression-free Survival (PFS) RateSecondary· From the date of beginning of lenvatinib administration up to the date of first documentation of confirmed disease progression or death, whichever occurred first (up to Week 12)
Twelve-week PFS rate was the percentage of participants in the analysis population who remain alive and progression-free at 12 weeks. PFS was defined as the time from the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurred first. The Kaplan-Meier estimated rate method was used to estimate 12-week PFS, along with the corresponding 95% confidence interval (CI). Participants who were off study due to lost to follow up, withdrew consent, or study terminated by sponsor, had new anti-cancer treatment, had no
Group
Value
95% CI
Lenvatinib 24 mg
36.4
20.6 – 52.3
Overall Survival (OS) RateSecondary· From the date of beginning of lenvatinib administration up to date of death from any cause (up to Month 6)
Six-month OS rate was defined as the percentage of participants in the analysis population who are alive at 6 months. OS was defined as the time from the date of beginning of lenvatinib administration until date of death from any cause. The Kaplan-Meier estimated rate method was used to estimate six-month OS, along with the corresponding 95% CI. Participants with last known alive date as study terminated by sponsor were censored.
Group
Value
95% CI
Lenvatinib 24 mg
41.2
24.8 – 56.9
Median PFSSecondary· From the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurred first (up to Month 27)
PFS was defined as the time from the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. Participants who were off study due to lost to follow up, withdrew consent, or study terminated by sponsor, had new anti-cancer treatment, had no baseline/post-baseline tumor assessments, or missed 2 or more visits prior to event were censored.
Group
Value
95% CI
Lenvatinib 24 mg
2.6
1.4 – 2.8
Median OSSecondary· From the date of beginning of lenvatinib administration up to date of death from any cause (up to Month 27)
OS was defined as the time from the date of beginning of lenvatinib administration until date of death from any cause. Median OS was estimated using the Kaplan-Meier method. Participants with last known alive date as study terminated by sponsor were censored.
Group
Value
95% CI
Lenvatinib 24 mg
3.2
2.8 – 8.2
Adverse events — posted to ClinicalTrials.gov
Time frame: From signature of informed consent form up to 28 days after last dose of study drug (up to Month 27).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Lenvatinib
Serious: 25/34 (74%)
Deaths: 27/34
Serious adverse events (44 terms)
Reaction
System
Lenvatinib
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
Hypertension
Vascular disorders
—
Asthenia
General disorders
—
Pyrexia
General disorders
—
Presyncope
Nervous system disorders
—
Dysphagia
Gastrointestinal disorders
—
Dehydration
Metabolism and nutrition disorders
—
Hyponatraemia
Metabolism and nutrition disorders
—
Deep vein thrombosis
Vascular disorders
—
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Metastases to peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Chest pain
General disorders
—
Non-cardiac chest pain
General disorders
—
Confusional state
Psychiatric disorders
—
Accidental overdose
Injury, poisoning and procedural complications
—
Cardiopulmonary failure
Cardiac disorders
—
Abdominal lymphadenopathy
Blood and lymphatic system disorders
—
Agranulocytosis
Blood and lymphatic system disorders
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
—
Pneumothorax
Respiratory, thoracic and mediastinal disorders
—
Other adverse events (189 terms — click to expand)
The primary purpose of the study is to evaluate objective response rate (\[ORR\]: complete response \[CR\] and partial response \[PR\]) by investigator review in participants with anaplastic thyroid cancer (ATC) treated with lenvatinib.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants
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· recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants
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· recruiting
NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P
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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: 15 October 2019
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/NCT02657369.