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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) (SELECT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321554
First Posted: March 23, 2011
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
Results First Submitted: March 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Thyroid Cancer
Interventions: Drug: Lenvatinib
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 612 subjects were screened for entry into the study. Of these 612 subjects, 220 subjects were screening failures and 392 subjects were randomly assigned to receive either lenvatinib or placebo in a 2:1 ratio.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lenvatinib (Randomization Phase) Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
Placebo (Randomization Phase) Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
Lenvatinib 24 mg (OOL Lenvatinib Treatment Period) Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib
Lenvatinib 20 mg (OOL Lenvatinib Treatment Period) Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. The starting dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The starting dose was lowered at the request of the Data Monitoring Committee to 20mg on 16 Feb 2013.

Participant Flow for 2 periods

Period 1:   Randomization Phase
    Lenvatinib (Randomization Phase)   Placebo (Randomization Phase)   Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)   Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)
STARTED   261   131   0   0 
Treatment Ongoing at Data Cutoff   122   8   0   0 
Discontinued Due to Disease Progression   94   119   0   0 
COMPLETED   216 [1]   127 [1]   0   0 
NOT COMPLETED   45   4   0   0 
Adverse Event                37                3                0                0 
Participant choice                4                0                0                0 
Withdrawal by Subject                4                0                0                0 
Death                0                1                0                0 
[1] Discontinued due to disease progression or treatment ongoing at data cut off (15 Nov 2013)

Period 2:   OOL Lenvatinib Treatment Period
    Lenvatinib (Randomization Phase)   Placebo (Randomization Phase)   Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)   Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)
STARTED   0   0   82   27 
Treatment Ongoing at Data Cutoff   0   0   36   22 
Discontinued Due to Disease Progression   0   0   18   3 
COMPLETED   0   0   54 [1]   25 [1] 
NOT COMPLETED   0   0   28   2 
Adverse Event                0                0                16                1 
Participant choice                0                0                3                0 
Withdrawal by Subject                0                0                1                0 
Not specified                0                0                5                0 
Lost to Follow-up                0                0                1                0 
Worsening disease                0                0                1                0 
Death                0                0                1                1 
[1] Discontinued due to disease progression or treatment ongoing at data cut off (15 Nov 2013)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lenvatinib (Randomization Phase) Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
Placebo (Randomization Phase) Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
Total Total of all reporting groups

Baseline Measures
   Lenvatinib (Randomization Phase)   Placebo (Randomization Phase)   Total 
Overall Participants Analyzed 
[Units: Participants]
 261   131   392 
Age 
[Units: Years]
Geometric Mean (Standard Deviation)
 62.1  (10.57)   61.5  (10.09)   61.9  (10.40) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      136  52.1%      56  42.7%      192  49.0% 
Male      125  47.9%      75  57.3%      200  51.0% 


  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ 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 ]

2.  Secondary:   Overall Response Rate (ORR)   [ 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 ]

3.  Secondary:   Overall Survival (OS)   [ 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 ]

4.  Secondary:   Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve   [ Time Frame: Cycle 1 Day 1 through Cycle 6 Day 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Eisai Medical Services
Organization: Eisai, Inc.
phone: 1-888-422-4743
e-mail: esi_medinfo@eisai.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01321554     History of Changes
Other Study ID Numbers: E7080-G000-303
First Submitted: March 10, 2011
First Posted: March 23, 2011
Results First Submitted: March 13, 2015
Results First Posted: December 12, 2016
Last Update Posted: May 15, 2017