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Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01327885
First received: March 31, 2011
Last updated: January 6, 2017
Last verified: January 2017
Results First Received: January 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Soft Tissue Sarcoma
Interventions: Drug: Eribulin mesylate 1.4 mg/m^2 intravenous
Drug: Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV

  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
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Reporting Groups
  Description
Arm A: Eribulin Mesylate Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
Arm B: Dacarbazine Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.

Participant Flow:   Overall Study
    Arm A: Eribulin Mesylate   Arm B: Dacarbazine
STARTED   228   224 
COMPLETED   0   0 
NOT COMPLETED   228   224 
Disease progression-according to RECIST                173                165 
Clinical progression                24                27 
Adverse Event                14                10 
Subject choice                5                10 
Not specified                8                6 
Withdrawal of consent from study                2                4 
Not treated                1                1 
Ongoing                1                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 (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.

Reporting Groups
  Description
Arm A: Eribulin Mesylate Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
Arm B: Dacarbazine Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Total Total of all reporting groups

Baseline Measures
   Arm A: Eribulin Mesylate   Arm B: Dacarbazine   Total 
Overall Participants Analyzed 
[Units: Participants]
 228   224   452 
Age 
[Units: Years]
Geometric Mean (Standard Deviation)
 55.6  (11.01)   55.7  (10.35)   55.7  (10.68) 
Gender 
[Units: Participants]
Count of Participants
     
Female      161  70.6%      142  63.4%      303  67.0% 
Male      67  29.4%      82  36.6%      149  33.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: From date of treatment start until date of death from any cause, assessed up to data cutoff date (02 Jan 2015), for up to approximately 3 years 11 months ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Randomization (day 1) to the date of first documentation of disease progression, or date of death (whichever occurred first) ]

3.  Secondary:   Progression-Free Rate at 12 Weeks (PFR12wks)   [ Time Frame: From date of treatment start until Week 12 ]

4.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: From date of treatment start (Day 1) until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff (02 Jan 2015), for up to approximately 3 years 11 months ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Eisai Medical Services
Organization: Eisai Inc.
phone: 1-888-422-4743


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

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01327885     History of Changes
Other Study ID Numbers: E7389-G000-309
Study First Received: March 31, 2011
Results First Received: January 6, 2017
Last Updated: January 6, 2017