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E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma

This study has been completed.
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01133977
First received: May 21, 2010
Last updated: August 16, 2016
Last verified: August 2016
Results First Received: March 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stage IV Melanoma
Interventions: Drug: Lenvatinib
Drug: Dacarbazine

  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 16 participants were enrolled in the Phase 1b portion of the study; all 16 participants received study treatment. A total of 82 participants were randomized in the Phase 2 portion of the study and a total of 81 participants received treatment. In the Darcarbazine arm, one participant withdrew consent prior to receiving study treatment.

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
16 mg Lenvatinib + Dacarbazine (Phase 1b) Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
20 mg Lenvatinib + Dacarbazine (Phase 1b) Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
22 mg Lenvatinib + Dacarbazine (Phase 1b) Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
20 mg Lenvatinib + Dacarbazine (Phase 2) Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
Dacarbazine (Phase 2) Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit

Participant Flow:   Overall Study
    16 mg Lenvatinib + Dacarbazine (Phase 1b)   20 mg Lenvatinib + Dacarbazine (Phase 1b)   22 mg Lenvatinib + Dacarbazine (Phase 1b)   20 mg Lenvatinib + Dacarbazine (Phase 2)   Dacarbazine (Phase 2)
STARTED   3 [1]   7 [1]   6 [1]   42 [1]   39 [1] 
COMPLETED   0   0   0   3   1 
NOT COMPLETED   3   7   6   39   38 
Adverse Event                0                0                1                0                0 
Death                1                1                1                7                3 
Started a New Line of Therapy                2                6                4                25                33 
Lost to Follow-up                0                0                0                2                1 
Withdrawal by Subject                0                0                0                5                1 
[1] Treated



  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.
A total of 40 participants were randomized in Dacarbazine (Phase 2) arm but only 39 participants received study drug and were included in the safety analysis set.

Reporting Groups
  Description
16 mg Lenvatinib + Dacarbazine (Phase 1b) Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
20 mg Lenvatinib + Dacarbazine (Phase 1b) Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
22 mg Lenvatinib + Dacarbazine (Phase 1b) Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
20 mg Lenvatinib + Dacarbazine (Phase 2) Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
Dacarbazine (Phase 2) Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
Total Total of all reporting groups

Baseline Measures
   16 mg Lenvatinib + Dacarbazine (Phase 1b)   20 mg Lenvatinib + Dacarbazine (Phase 1b)   22 mg Lenvatinib + Dacarbazine (Phase 1b)   20 mg Lenvatinib + Dacarbazine (Phase 2)   Dacarbazine (Phase 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   7   6   42   39   97 
Age, Customized 
[Units: Participants]
           
18 years and older   3   7   6   42   39   97 
Gender, Customized 
[Units: Participants]
           
Male   3   2   4   25   23   57 
Female   0   5   2   17   16   40 


  Outcome Measures
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1.  Primary:   Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)   [ Time Frame: From Day 1 through 21 days (one cycle) ]

2.  Primary:   Number of Participants With Adverse Events/Serious Adverse Events (AEs/SAEs)   [ Time Frame: From signing of informed consent up to 30 days after the last dose, up to approximately 2 years ]

3.  Secondary:   Progression Free Survival (PFS) (for Phase 2)   [ Time Frame: From the date of randomization until the date of disease progression or death (whichever was earlier) or up to approximately 2 years ]

4.  Other Pre-specified:   Time to Progression (TTP) (for Phase 2)   [ Time Frame: From the date of randomization until disease progression or death or up to approximately 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Overall Survival (OS) (for Phase 2)   [ Time Frame: From the date of randomization until death or up to approximately 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Overall Response Rate (ORR) (for Phase 2)   [ Time Frame: From the date of randomization until disease progression or death or up to approximately 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01133977     History of Changes
Other Study ID Numbers: E7080-702
Study First Received: May 21, 2010
Results First Received: March 13, 2015
Last Updated: August 16, 2016