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E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00413192
First received: December 15, 2006
Last updated: March 27, 2017
Last verified: January 2017
Results First Received: February 2, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Soft Tissue Sarcoma
Intervention: Drug: E7389

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 128 participants were enrolled. Of these 128 participants115 were eligible to continue in the study following reassessment of study eligibility in which 12 participants previously found eligible and began treatment, were then assessed as ineligible. One participant was not treated.

Reporting Groups
  Description
Adipocyte Tumors (ADI) Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Leiomyosarcoma (LMS) Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Synovial Sarcoma (SYN) Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Other Types of Sarcoma (OTH) Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participant Flow:   Overall Study
    Adipocyte Tumors (ADI)   Leiomyosarcoma (LMS)   Synovial Sarcoma (SYN)   Other Types of Sarcoma (OTH)
STARTED   37   40   19   32 
COMPLETED   0   0   0   0 
NOT COMPLETED   37   40   19   32 
Disease progression                26                31                16                25 
Toxicity                3                2                2                2 
Withdrawal by Subject                3                5                0                1 
Intercurrent illness                0                0                0                1 
Intercurrent death                0                1                0                0 
Not specified                5                1                1                2 
Not treated                0                0                0                1 



  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.
Full analysis set consisted of all enrolled subjects who received at least one dose of study drug, regardless of their eligibility to enter the study.

Reporting Groups
  Description
Adipocyte Tumors (ADI) Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Leiomyosarcoma (LMS) Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Synovial Sarcoma (SYN) Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Other Types of Sarcoma (OTH) Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Total Total of all reporting groups

Baseline Measures
   Adipocyte Tumors (ADI)   Leiomyosarcoma (LMS)   Synovial Sarcoma (SYN)   Other Types of Sarcoma (OTH)   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   40   19   31   127 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.1  (11.35)   59.9  (12.69)   43.7  (17.92)   53.1  (15.21)   54.4  (14.66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      11  29.7%      32  80.0%      5  26.3%      18  58.1%      66  52.0% 
Male      26  70.3%      8  20.0%      14  73.7%      13  41.9%      61  48.0% 


  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS) at 12 Weeks   [ Time Frame: Week 12 ]

2.  Secondary:   Overall Progression Free Survival   [ Time Frame: First dose of study drug to the date of disease progression or date of death, whichever occurs first, or date of study cut-off 28 Jun 2012, up to 5.5 years ]

3.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Date of first dose of study drug until documentation of CR or PR, or up to data cutoff 28 Jun 2012, up to approximately 5.5 years ]

4.  Secondary:   Clinical Response Benefit (CRB)   [ Time Frame: Date of first dose of study drug to documentation of CR, PR, or SD, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years ]

5.  Secondary:   Time to Onset of Response   [ Time Frame: Date of first dose of study drug to date of first documented CR or PR, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years ]

6.  Secondary:   Duration of Response   [ Time Frame: Date of first documented CR or PR until the date of first document disease progression (or death), or up to data cutoff 28 Jun 2012, up to approximately 5.5 years ]

7.  Secondary:   Overall Survival (OS)   [ Time Frame: Date of first dose of study drug to date of death from any cause, or up to cut-off date of 28 Jun 2012, up to approximately 5.5 years ]

8.  Secondary:   Summary of Adverse Events (AEs)   [ Time Frame: Day 1 of study treatment until progressive disease, or up to cut-off date of 28 Jun 2012, up to approximately 5.5 years ]


  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: Gitta Irmer Associate Director, Data Quality & Standards Global Regulatory Operations
Organization: Eisai Ltd. Mosquito Way, Hatfield, Hertfordshire, AL 10 9SN
phone: +44 (0) 845 676 1618


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

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00413192     History of Changes
Other Study ID Numbers: E7389-E044-207
2005-004272-20 ( EudraCT Number )
Study First Received: December 15, 2006
Results First Received: February 2, 2017
Last Updated: March 27, 2017