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

Primary Purpose

Thyroid Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenvatinib
Placebo
Lenvatinib
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Histologically or cytologically confirmed diagnosis of one of the following DTC subtypes: Papillary thyroid cancer (PTC) or follicular thyroid cancer (FTC).
  2. Measurable disease according to (RECIST 1.1) and confirmed by central radiographic review.
  3. 131 I-refractory/resistant disease.
  4. Evidence of disease progression within 12 months prior to signing informed consent (+1 month screening window).
  5. Prior treatment with 0 or 1 vascular endothelial growth-factor (VEGF) or vascular endothelial growth-factor receptors (VEGFR) targeted therapy.
  6. Adequate renal, liver, bone marrow, and blood coagulation function, as defined in the protocol.

Exclusion criteria:

  1. Anaplastic or medullary carcinoma of the thyroid
  2. 2 or more prior VEGF/ VEGFR-targeted therapies
  3. Received any anticancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug.

Inclusion criteria for OOL Lenvatinib Treatment Period :

Participants were eligible for lenvatinib treatment in the OOL Lenvatinib Treatment Period if the met the following criteria:

  1. Placebo-treated participants in the Randomization Phase who had progressive disease (PD) confirmed by IIR, and who requested treatment with lenvatinib.
  2. Participants who continued to satisfy specified inclusion and exclusion criteria as presented in the study protocol.
  3. Participants with maximum interval between the day of confirmation of PD by IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period of less than or equal to 3 months.
  4. No systemic anticancer treatment during the interval between the day of confirmation of PD by the IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period.

Sites / Locations

  • Facility 1
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  • Eisai Trial Site 1
  • Eisai Trial Site 2
  • Eisai Trial Site 1
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  • Eisai Trial Site 1
  • Eisai Trial Site 1
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Lenvatinib (Randomization Phase)

Placebo (Randomization Phase)

Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)

Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)

Arm Description

Participants randomly assigned in a 2:1 ratio to receive blinded study drug (lenvatinib or matching placebo) until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.

Participants randomly assigned in a 2:1 ratio to receive blinded study drug (lenvatinib or matching placebo) until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.

Participants will receive lenvatinib 24 mg, orally once daily until documentation of disease progression (confirmed by investigator's assessment), development of unacceptable toxicity, or withdrawal of consent. Placebo treated participants in the Randomization Phase who have progressive disease confirmed by IIR could request to receive lenvatinib treatment in the OOL Treatment Period.

Participants will receive lenvatinib 20 mg, orally once daily until documentation of disease progression (confirmed by investigator's assessment), development of unacceptable toxicity, or withdrawal of consent. Placebo treated participants in the Randomization Phase who have progressive disease confirmed by IIR could request to receive lenvatinib treatment in the OOL Treatment Period.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
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 Outcome Measures

Overall Response Rate (ORR)
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.
Overall Survival (OS)
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.
Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve

Full Information

First Posted
March 10, 2011
Last Updated
June 16, 2023
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01321554
Brief Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)
Acronym
SELECT
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 17, 2011 (Actual)
Primary Completion Date
November 15, 2013 (Actual)
Study Completion Date
March 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment Period and a follow-up period).
Detailed Description
Randomization Phase: Participants will receive blinded study drug (lenvatinib/placebo) in 2:1 ratio until documentation of disease progression (confirmed by independent imaging review), development of unacceptable toxicity, or withdrawal of consent. After having completed the primary analysis, subjects treated with lenvatinib who have not experienced disease progression may request to continue open label lenvatinib at the same dose, according to the clinical judgment of the investigator. Participants who discontinue treatment for any reason other than disease progression will be followed in the Randomization Phase until disease progression or start of another anticancer treatment; these participants then enter the Extension Phase for survival follow-up. Extension Phase: Participants in the placebo arm who have disease progression confirmed by IIR could request to enter the OOL Lenvatinib Treatment Period and receive lenvatinib treatment. Participants will receive lenvatinib treatment until disease progression (investigator's assessment), development of intolerable toxicity, or withdrawal of consent. Participants who had disease progression during the Randomization Phase and did not enter the OOL Lenvatinib Treatment Period and all participants who discontinued lenvatinib treatment in the OOL Lenvatinib Treatment Period will enter the follow-up period. Participants will be followed for survival, and all anticancer treatments will be recorded until the time of death.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenvatinib (Randomization Phase)
Arm Type
Experimental
Arm Description
Participants randomly assigned in a 2:1 ratio to receive blinded study drug (lenvatinib or matching placebo) until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
Arm Title
Placebo (Randomization Phase)
Arm Type
Placebo Comparator
Arm Description
Participants randomly assigned in a 2:1 ratio to receive blinded study drug (lenvatinib or matching placebo) until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
Arm Title
Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)
Arm Type
Experimental
Arm Description
Participants will receive lenvatinib 24 mg, orally once daily until documentation of disease progression (confirmed by investigator's assessment), development of unacceptable toxicity, or withdrawal of consent. Placebo treated participants in the Randomization Phase who have progressive disease confirmed by IIR could request to receive lenvatinib treatment in the OOL Treatment Period.
Arm Title
Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)
Arm Type
Experimental
Arm Description
Participants will receive lenvatinib 20 mg, orally once daily until documentation of disease progression (confirmed by investigator's assessment), development of unacceptable toxicity, or withdrawal of consent. Placebo treated participants in the Randomization Phase who have progressive disease confirmed by IIR could request to receive lenvatinib treatment in the OOL Treatment Period.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
Lenvatinib (Lenvima, E7080)
Intervention Description
Lenvatinib 24 mg (two 10-mg and one 4-mg lenvatinib matched capsules) taken orally once daily, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo (two 10-mg and one 4-mg lenvatinib matched capsules) taken orally once daily, continuously.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
Lenvatinib (Lenvima, E7080)
Intervention Description
Lenvatinib 20 mg (two 10-mg capsules) taken orally once daily, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity. The dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The dose was lowered at the request of the Data Monitoring Committee to 20 mg on 16 Feb 2013. Thus, more subjects were treated with 24 mg starting dose and the treatment duration was longer for these participants than those whose starting dose was 20 mg.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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 Frame
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
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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 Frame
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
Title
Overall Survival (OS)
Description
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 Frame
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
Title
Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve
Time Frame
Cycle 1 Days 1 and 15: 0-10 hours postdose; Cycle 2 Day 1: 0-12 hour postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Histologically or cytologically confirmed diagnosis of one of the following DTC subtypes: Papillary thyroid cancer (PTC) or follicular thyroid cancer (FTC). Measurable disease according to (RECIST 1.1) and confirmed by central radiographic review. 131 I-refractory/resistant disease. Evidence of disease progression within 12 months prior to signing informed consent (+1 month screening window). Prior treatment with 0 or 1 vascular endothelial growth-factor (VEGF) or vascular endothelial growth-factor receptors (VEGFR) targeted therapy. Adequate renal, liver, bone marrow, and blood coagulation function, as defined in the protocol. Exclusion criteria: Anaplastic or medullary carcinoma of the thyroid 2 or more prior VEGF/ VEGFR-targeted therapies Received any anticancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug. Inclusion criteria for OOL Lenvatinib Treatment Period : Participants were eligible for lenvatinib treatment in the OOL Lenvatinib Treatment Period if the met the following criteria: Placebo-treated participants in the Randomization Phase who had progressive disease (PD) confirmed by IIR, and who requested treatment with lenvatinib. Participants who continued to satisfy specified inclusion and exclusion criteria as presented in the study protocol. Participants with maximum interval between the day of confirmation of PD by IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period of less than or equal to 3 months. No systemic anticancer treatment during the interval between the day of confirmation of PD by the IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period.
Facility Information:
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Little Rock
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Arkansas
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United States
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La Jolla
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United States
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Los Gatos
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Mission Viejo
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Orange
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Orange
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Sacramento
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United States
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Torrance
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Aurora
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Washington
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United States
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Orlando
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Weston
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United States
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Chicago
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Illinois
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United States
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Chicago
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Illinois
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United States
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Indianapolis
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United States
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Lexington
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Baltimore
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Boston
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Boston
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United States
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Detroit
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United States
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Lansing
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Minneapolis
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Columbia
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Omaha
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United States
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Lebanon
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United States
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Morristown
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United States
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Neptune
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New Jersey
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United States
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Bronx
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New York
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United States
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New York
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New York
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United States
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New York
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New York
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United States
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Columbus
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Ohio
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United States
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Portland
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Oregon
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United States
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Philadelphia
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United States
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Philadelphia
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United States
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Houston
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United States
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Seattle
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United States
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Morgantown
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West Virginia
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United States
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Milwaukee
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Wisconsin
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United States
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Rosario
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Argentina
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Facility 1
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San Salvador de Jujuy
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Argentina
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Facility 1
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Tucuman
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Argentina
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Facility 1
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Saint Leonards
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New South Wales
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Australia
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Facility 1
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Herston
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Queensland
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Australia
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Facility 1
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Hobart
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Tasmania
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Australia
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Melbourne
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Victoria
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Australia
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Heidelberg
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Australia
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Wien
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Austria
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Bruxelles
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Belgium
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Edegem
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Belgium
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Namur
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Belgium
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Brasilia
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Brazil
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Joinville
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Brazil
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Novo Hamburgo
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Brazil
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Facility 1
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Rio de Janeiro
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Brazil
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Facility 1
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Salvador
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Brazil
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Sao Paulo
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Brazil
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Sao Paulo
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Brazil
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London
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Ontario
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Canada
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Facility 1
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Toronto
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Ontario
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Canada
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Facility 1
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Montreal
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Quebec
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Canada
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Facility 1
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Quebec
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Canada
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Facility 1
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Santiago
Country
Chile
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Facility 2
City
Santiago
Country
Chile
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Facility 3
City
Santiago
Country
Chile
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Facility 1
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Temuco
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Chile
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Facility 1
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Vina del Mar
Country
Chile
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Facility 1
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Olomouc
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Czechia
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Facility 1
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Odense
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Denmark
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Angers
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France
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Bordeaux
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France
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Caen
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France
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Clermont-Ferrand
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France
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Dijon
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France
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Facility 1
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Lille
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France
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Facility 1
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Lyon
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France
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Marseille
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France
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Nice
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France
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Paris
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France
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Paris
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France
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Strasbourg
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France
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Facility 1
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Vandoeuvre Les Nancy
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France
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Facility 1
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Villejuif
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France
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Facility 1
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Essen
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Germany
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Facility 1
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Hannover
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Germany
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Facility 1
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Leipzig
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Germany
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Facility 1
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Mainz
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Germany
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Facility 1
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Munchen
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Germany
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Facility 1
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Tubingen
Country
Germany
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Facility 1
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Wurzburg
Country
Germany
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Facility 1
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Catania
Country
Italy
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Facility 1
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Livorno
Country
Italy
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Facility 1
City
Milano
Country
Italy
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Facility 2
City
Milano
Country
Italy
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Facility 3
City
Milano
Country
Italy
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Facility 4
City
Milano
Country
Italy
Facility Name
Facility 5
City
Milano
Country
Italy
Facility Name
Facility 1
City
Monserrato
Country
Italy
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Facility 1
City
Napoli
Country
Italy
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Facility 1
City
Padova
Country
Italy
Facility Name
Facility 1
City
Pisa
Country
Italy
Facility Name
Facility 1
City
Roma
Country
Italy
Facility Name
Facility 2
City
Roma
Country
Italy
Facility Name
Facility 1
City
Rozzano
Country
Italy
Facility Name
Facility 1
City
Torino
Country
Italy
Facility Name
Facility 1
City
Viagrande
Country
Italy
Facility Name
Eisai Trial Site 1
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Eisai Trial Site 2
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Eisai Trial Site 1
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
Eisai Trial Site 1
City
Fukui-city
State/Province
Fukui
Country
Japan
Facility Name
Eisai Trial Site 1
City
Kobe-city
State/Province
Hyogo
Country
Japan
Facility Name
Eisai Trial Site 1
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Facility 1
City
Daejeon
Country
Korea, Republic of
Facility Name
Facility 1
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Facility 1
City
Seoul
Country
Korea, Republic of
Facility Name
Facility 2
City
Seoul
Country
Korea, Republic of
Facility Name
Facility 3
City
Seoul
Country
Korea, Republic of
Facility Name
Facility 1
City
Uijeongbu
Country
Korea, Republic of
Facility Name
Facility 1
City
Gliwice
Country
Poland
Facility Name
Facility 1
City
Kielce
Country
Poland
Facility Name
Facility 1
City
Poznan
Country
Poland
Facility Name
Facility 1
City
Lisbon
Country
Portugal
Facility Name
Facility 1
City
Porto
Country
Portugal
Facility Name
Facility 1
City
Bucharest
Country
Romania
Facility Name
Facility 2
City
Bucharest
Country
Romania
Facility Name
Facility 1
City
Cluj-Napoca
Country
Romania
Facility Name
Facility 1
City
Krasnodar
Country
Russian Federation
Facility Name
Facility 1
City
Kursk
Country
Russian Federation
Facility Name
Facility 1
City
Obninsk
Country
Russian Federation
Facility Name
Facility 1
City
Ufa
Country
Russian Federation
Facility Name
Facility 2
City
Malaga
State/Province
Andalucia
Country
Spain
Facility Name
Facility 1
City
Barcelona
State/Province
Cataluna
Country
Spain
Facility Name
Facility 1
City
La Coruna
State/Province
Galicia
Country
Spain
Facility Name
Facility 2
City
Barcelona
Country
Spain
Facility Name
Facility 1
City
L'Hospitalet de Llobregat
Country
Spain
Facility Name
Facility 1
City
Madrid
Country
Spain
Facility Name
Facility 2
City
Madrid
Country
Spain
Facility Name
Facility 3
City
Madrid
Country
Spain
Facility Name
Facility 4
City
Madrid
Country
Spain
Facility Name
Facility 5
City
Madrid
Country
Spain
Facility Name
Facility 1
City
Goteborg
Country
Sweden
Facility Name
Facility 1
City
Lund
Country
Sweden
Facility Name
Facility 1
City
Stockholm
Country
Sweden
Facility Name
Facility 1
City
Bangkok
Country
Thailand
Facility Name
Facility 2
City
Bangkok
Country
Thailand
Facility Name
Facility 1
City
Chiang Mai
Country
Thailand
Facility Name
Facility 1
City
Khon Kaen
Country
Thailand
Facility Name
Facility 1
City
Pathumwan
Country
Thailand
Facility Name
Facility 1
City
Aberdeen
Country
United Kingdom
Facility Name
Facility 1
City
Glasgow
Country
United Kingdom
Facility Name
Facility 2
City
London
Country
United Kingdom
Facility Name
Facility 3
City
London
Country
United Kingdom
Facility Name
Facility 1
City
Manchester
Country
United Kingdom
Facility Name
Facility 2
City
Manchester
Country
United Kingdom
Facility Name
Facility 1
City
Sheffield
Country
United Kingdom
Facility Name
Facility 1
City
Sutton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33637020
Citation
Taylor MH, Takahashi S, Capdevila J, Tahara M, Leboulleux S, Kiyota N, Dutcus CE, Xie R, Robinson B, Sherman S, Habra MA, Elisei R, Wirth LJ. Correlation of Performance Status and Neutrophil-Lymphocyte Ratio with Efficacy in Radioiodine-Refractory Differentiated Thyroid Cancer Treated with Lenvatinib. Thyroid. 2021 Aug;31(8):1226-1234. doi: 10.1089/thy.2020.0779. Epub 2021 Apr 29.
Results Reference
derived
PubMed Identifier
33611104
Citation
Tahara M, Kiyota N, Hoff AO, Badiu C, Owonikoko TK, Dutcus CE, Suzuki T, Ren M, Wirth LJ. Impact of lung metastases on overall survival in the phase 3 SELECT study of lenvatinib in patients with radioiodine-refractory differentiated thyroid cancer. Eur J Cancer. 2021 Apr;147:51-57. doi: 10.1016/j.ejca.2020.12.032. Epub 2021 Feb 19.
Results Reference
derived
PubMed Identifier
30471649
Citation
Tahara M, Brose MS, Wirth LJ, Suzuki T, Miyagishi H, Fujino K, Dutcus CE, Gianoukakis A. Impact of dose interruption on the efficacy of lenvatinib in a phase 3 study in patients with radioiodine-refractory differentiated thyroid cancer. Eur J Cancer. 2019 Jan;106:61-68. doi: 10.1016/j.ejca.2018.10.002. Epub 2018 Nov 22.
Results Reference
derived
PubMed Identifier
28237867
Citation
Tahara M, Schlumberger M, Elisei R, Habra MA, Kiyota N, Paschke R, Dutcus CE, Hihara T, McGrath S, Matijevic M, Kadowaki T, Funahashi Y, Sherman SI. Exploratory analysis of biomarkers associated with clinical outcomes from the study of lenvatinib in differentiated cancer of the thyroid. Eur J Cancer. 2017 Apr;75:213-221. doi: 10.1016/j.ejca.2017.01.013. Epub 2017 Feb 24.
Results Reference
derived
PubMed Identifier
27548104
Citation
Robinson B, Schlumberger M, Wirth LJ, Dutcus CE, Song J, Taylor MH, Kim SB, Krzyzanowska MK, Capdevila J, Sherman SI, Tahara M. Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer. J Clin Endocrinol Metab. 2016 Nov;101(11):4103-4109. doi: 10.1210/jc.2015-3989. Epub 2016 Aug 22.
Results Reference
derived
PubMed Identifier
26426092
Citation
Kiyota N, Schlumberger M, Muro K, Ando Y, Takahashi S, Kawai Y, Wirth L, Robinson B, Sherman S, Suzuki T, Fujino K, Gupta A, Hayato S, Tahara M. Subgroup analysis of Japanese patients in a phase 3 study of lenvatinib in radioiodine-refractory differentiated thyroid cancer. Cancer Sci. 2015 Dec;106(12):1714-21. doi: 10.1111/cas.12826. Epub 2015 Nov 2.
Results Reference
derived
PubMed Identifier
25671254
Citation
Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. doi: 10.1056/NEJMoa1406470.
Results Reference
derived

Learn more about this trial

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

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