ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma

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.
ClinicalTrials.gov Identifier: NCT01136967
Recruitment Status : Completed
First Posted : June 4, 2010
Results First Posted : March 16, 2016
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Unresectable Stage III
Stage IV Melanoma
Intervention: Drug: Lenvatinib

  Participant Flow

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 298 participants were screened. Of these, 116 were screen failures and 182 received treatment (93 participants in Cohort 1 and 89 participants in Cohort 2).

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
Cohort 1 (V600E BRAF Negative) Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Cohort 2 (V600E BRAF Positive) Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.

Participant Flow:   Overall Study
    Cohort 1 (V600E BRAF Negative)   Cohort 2 (V600E BRAF Positive)
STARTED   93   89 
Disease Progression   55   56 
Treatment Ongoing at Data Cutoff   14 [1]   6 [2] 
COMPLETED   69 [3]   62 [4] 
NOT COMPLETED   24   27 
Adverse Event                9                12 
Participant Choice                8                3 
Lost to Follow-up                0                1 
Withdrawal by Subject                1                2 
Clinical Progression                3                5 
Radiation                1                0 
Non Compliance                1                0 
Investigator's Choice                1                1 
Increase in Lesion Size                0                2 
Diagnosis of Second Primary Cancer                0                1 
[1] Entered Extension Phase on treatment at data cut-off (18 January 2012)
[2] Entered Extension Phase on treatment at data cut-off (15 April 2013)
[3] Disease Progression and treatment ongoing at data cutoff (18 January 2012)
[4] Disease Progression and treatment ongoing at data cutoff (15 April 2013)



  Baseline Characteristics

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
Cohort 1 (V600E BRAF Negative) Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Cohort 2 (V600E BRAF Positive) Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Total Total of all reporting groups

Baseline Measures
   Cohort 1 (V600E BRAF Negative)   Cohort 2 (V600E BRAF Positive)   Total 
Overall Participants Analyzed 
[Units: Participants]
 93   89   182 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.5  (11.71)   55.0  (14.18)   58.8  (13.47) 
Gender 
[Units: Participants]
     
Female   29   39   68 
Male   64   50   114 
AJCC Melanoma Tumor, Node, Metastasis (TNM) Stage at Study Entry 
[Units: Participants]
     
Unresectable Stage III   5   7   12 
Unresectable Stage IV   88   82   170 


  Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: From date of first dose of study drug until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to end of Cycle 6 by the date of data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively) ]

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: From date of first dose of study drug until date of death from any cause or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years ]

4.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years ]

5.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years ]

6.  Secondary:   Number of Participants With Adverse Events (AEs)/ Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib   [ Time Frame: For each participant, from the first patient first dose till 30 days after the last dose of study drug, up to approximately 2.9 years ]

7.  Secondary:   Pharmacokinetics and Pharmacodynamics   [ Time Frame: Predose and 2 to 12 hours postdose at Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01136967     History of Changes
Other Study ID Numbers: E7080-G000-206
First Submitted: June 2, 2010
First Posted: June 4, 2010
Results First Submitted: March 13, 2015
Results First Posted: March 16, 2016
Last Update Posted: March 16, 2016