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← Thyroid Cancer

NCT01321554 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.

→

secondary · POSTED

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.

The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.

→

secondary · POSTED

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.

The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.

→

secondary · POSTED

Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve

The PK analysis set included all the participants who received at least one dose of study drug and had evaluable PK data.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT01321554
trial label
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
4
harms Count
4
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0000
    source section id
    NCT01321554-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    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.
    time origin
    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
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0001
    source section id
    NCT01321554-om-0001
    source outcome index
    1
    endpoint
    Overall Response Rate (ORR)
    endpoint definition
    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.
    time origin
    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
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0002
    source section id
    NCT01321554-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS)
    endpoint definition
    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.
    time origin
    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
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0003
    source section id
    NCT01321554-om-0003
    source outcome index
    3
    endpoint
    Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve
    endpoint definition
    Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve
    time origin
    Cycle 1 Days 1 and 15: 0-10 hours postdose; Cycle 2 Day 1: 0-12 hour postdose
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The PK analysis set included all the participants who received at least one dose of study drug and had evaluable PK data.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Randomization Phase: Lenvatinib 24 mg
    regimen
    Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    analyzed count
    261
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01321554-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Randomization Phase: Placebo
    regimen
    Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    analyzed count
    131
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01321554-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Randomization Phase: Lenvatinib 24 mg
    regimen
    Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    analyzed count
    261
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01321554-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Randomization Phase: Placebo
    regimen
    Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    analyzed count
    131
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01321554-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Randomization Phase: Lenvatinib 24 mg
    regimen
    Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    analyzed count
    261
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01321554-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Randomization Phase: Placebo
    regimen
    Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    analyzed count
    131
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01321554-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Randomization Phase: Lenvatinib 24 mg
    regimen
    Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    analyzed count
    260
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01321554-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    harm key
    EG000
    source section id
    NCT01321554-ae
    event group key
    EG000
    event group label
    Randomization Phase: Lenvatinib 24 mg
    serious affected
    171
    serious at risk
    261
    other affected
    259
    other at risk
    261
    frequency threshold
    5
    collection period
    For each participant, from the first dose till 30 days after the last dose up to approximately 8 years
    event definition
    Safety was assessed by the monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs); regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECG), and echocardiograms.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    harm key
    EG001
    source section id
    NCT01321554-ae
    event group key
    EG001
    event group label
    Randomization Phase: Placebo
    serious affected
    31
    serious at risk
    131
    other affected
    118
    other at risk
    131
    frequency threshold
    5
    collection period
    For each participant, from the first dose till 30 days after the last dose up to approximately 8 years
    event definition
    Safety was assessed by the monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs); regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECG), and echocardiograms.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    harm key
    EG002
    source section id
    NCT01321554-ae
    event group key
    EG002
    event group label
    OOL, Treatment Period: Lenvatinib 24 mg
    serious affected
    62
    serious at risk
    85
    other affected
    84
    other at risk
    85
    frequency threshold
    5
    collection period
    For each participant, from the first dose till 30 days after the last dose up to approximately 8 years
    event definition
    Safety was assessed by the monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs); regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECG), and echocardiograms.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-thyroid-cancer
    nct id
    NCT01321554
    harm key
    EG003
    source section id
    NCT01321554-ae
    event group key
    EG003
    event group label
    OOL, Treatment Period: Lenvatinib 20 mg
    serious affected
    16
    serious at risk
    30
    other affected
    29
    other at risk
    30
    frequency threshold
    5
    collection period
    For each participant, from the first dose till 30 days after the last dose up to approximately 8 years
    event definition
    Safety was assessed by the monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs); regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECG), and echocardiograms.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice