Trial · NCT01321554

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)

NCT01321554, Phase 3, Completed, Eisai Inc.; results first posted 2016-12-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC). Trials, record NCT01321554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01321554

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)
NCT number: NCT01321554
Status: Completed
Phases: Phase 3
Enrollment: 392 participants, actual
Lead sponsor: Eisai Inc.
Conditions: Thyroid Cancer
Interventions: Lenvatinib, Placebo, Lenvatinib
First posted: 2011-03-23
Last updated: 2023-06-22
Other registries' IDs: eudract:2010-023783-41
Results first posted: 2016-12-12

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS)	Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years	PFS was defined as the time from the date of randomization to the date of first documentation of disease progression or death (whichever occurred first), as determined by blinded IIR using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for the double-blind treatment period (Randomization Phase). 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 diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions.
Secondary	Overall Response Rate (ORR)	Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years	ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by blinded IIR using RECIST 1.1 for target lesions and assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans (for double blind treatment period i.e. Randomization Phase). 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. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Secondary	Overall Survival (OS)	Date of randomization until date of death from any cause, assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years	Overall survival measured from the date of randomization until date of death from any cause. Overall survival is adjusted with rank preserving structural failure time.
Secondary	Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve	Cycle 1 Days 1 and 15: 0-10 hours postdose; Cycle 2 Day 1: 0-12 hour postdose

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival (PFS)	Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years	The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.	months	MEDIAN
SECONDARY	Overall Response Rate (ORR)	Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years	The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Overall Survival (OS)	Date of randomization until date of death from any cause, assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years	The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.	months	MEDIAN
SECONDARY	Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve	Cycle 1 Days 1 and 15: 0-10 hours postdose; Cycle 2 Day 1: 0-12 hour postdose	The PK analysis set included all the participants who received at least one dose of study drug and had evaluable PK data.	nanogramhour per milliliter (ngh/mL)	MEDIAN

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival (PFS)	Randomization Phase: Lenvatinib 24 mg	18.3	95% Confidence Interval 15.1 to NA	months
Progression Free Survival (PFS)	Randomization Phase: Placebo	3.6	95% Confidence Interval 2.2 to 3.7	months
Overall Response Rate (ORR)	Randomization Phase: Lenvatinib 24 mg	64.8	95% Confidence Interval 59.0 to 70.5	percentage of participants
Overall Response Rate (ORR)	Randomization Phase: Placebo	1.5	95% Confidence Interval 0.0 to 3.6	percentage of participants
Overall Survival (OS)	Randomization Phase: Lenvatinib 24 mg	NA	95% Confidence Interval 22.0 to NA	months
Overall Survival (OS)	Randomization Phase: Placebo	NA	95% Confidence Interval 14.3 to NA	months
Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve	Randomization Phase: Lenvatinib 24 mg	3490	Full Range 1410 to 10700	nanogramhour per milliliter (ngh/mL)

Source ClinicalTrials.gov

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomization Phase	STARTED	Randomization Phase: Lenvatinib 24 mg	261
Randomization Phase	STARTED	Randomization Phase: Placebo	131
Randomization Phase	STARTED	OOL, Treatment Period: Lenvatinib 24 mg	0
Randomization Phase	STARTED	OOL, Treatment Period: Lenvatinib 20 mg	0
Randomization Phase	COMPLETED	Randomization Phase: Lenvatinib 24 mg	261
Randomization Phase	COMPLETED	Randomization Phase: Placebo	131
Randomization Phase	COMPLETED	OOL, Treatment Period: Lenvatinib 24 mg	0
Randomization Phase	COMPLETED	OOL, Treatment Period: Lenvatinib 20 mg	0
Randomization Phase	NOT COMPLETED	Randomization Phase: Lenvatinib 24 mg	0
Randomization Phase	NOT COMPLETED	Randomization Phase: Placebo	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events1,580

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Lymphopenia	Blood and lymphatic system disorders	Randomization Phase: Lenvatinib 24 mg	20	261	60
other	Lymphopenia	Blood and lymphatic system disorders	Randomization Phase: Placebo	2	131	2
other	Lymphopenia	Blood and lymphatic system disorders	OOL, Treatment Period: Lenvatinib 24 mg	0	85	0
other	Lymphopenia	Blood and lymphatic system disorders	OOL, Treatment Period: Lenvatinib 20 mg	0	30	0
other	Pelvic pain	Reproductive system and breast disorders	Randomization Phase: Lenvatinib 24 mg	0	261	0
other	Pelvic pain	Reproductive system and breast disorders	Randomization Phase: Placebo	0	131	0
other	Pelvic pain	Reproductive system and breast disorders	OOL, Treatment Period: Lenvatinib 24 mg	0	85	0
other	Pelvic pain	Reproductive system and breast disorders	OOL, Treatment Period: Lenvatinib 20 mg	3	30	4
other	Platelet count decreased	Investigations	Randomization Phase: Lenvatinib 24 mg	17	261	108
other	Platelet count decreased	Investigations	Randomization Phase: Placebo	0	131	0

1 to 10 of 1,580Source ClinicalTrials.gov

See all 1,580 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Randomization Phase: Lenvatinib 24 mg	161	261
Total, all-cause mortality	Randomization Phase: Placebo	13	16
Total, all-cause mortality	OOL, Treatment Period: Lenvatinib 24 mg	62	85
Total, all-cause mortality	OOL, Treatment Period: Lenvatinib 20 mg	15	30
Total, other adverse events	Randomization Phase: Lenvatinib 24 mg	259	261
Total, other adverse events	Randomization Phase: Placebo	118	131
Total, other adverse events	OOL, Treatment Period: Lenvatinib 24 mg	84	85
Total, other adverse events	OOL, Treatment Period: Lenvatinib 20 mg	29	30
Total, serious adverse events	Randomization Phase: Lenvatinib 24 mg	171	261
Total, serious adverse events	Randomization Phase: Placebo	31	131

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25671254	DERIVED	PubMed
26426092	DERIVED	PubMed
27548104	DERIVED	PubMed
28237867	DERIVED	PubMed
30471649	DERIVED	PubMed
33611104	DERIVED	PubMed
33637020	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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