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E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00400829
Recruitment Status : Completed
First Posted : November 17, 2006
Results First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Intervention: Drug: eribulin mesylate

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Arm I

Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

eribulin mesylate: Given IV


Participant Flow:   Overall Study
    Arm I
STARTED   66 
COMPLETED   66 
NOT COMPLETED   0 



  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
Arm I

Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

eribulin mesylate: Given IV


Baseline Measures
   Arm I 
Overall Participants Analyzed 
[Units: Participants]
 66 
Age 
[Units: Years]
Median (Full Range)
 63 
 (35 to 83) 
Gender 
[Units: Participants]
 
Female   35 
Male   31 
Region of Enrollment 
[Units: Participants]
 
United States   66 


  Outcome Measures

1.  Primary:   Objective Response Rate (CR or PR) According to RECIST Criteria   [ Time Frame: Tumor measurements repeated every 6 weeks ]

2.  Secondary:   Overall Survival   [ Time Frame: From start of treatment to death from any cause, assessed up to 5 years ]

3.  Secondary:   Progression Free Survival   [ Time Frame: From start of treatment to the time of documented progression, assessed up to 5 years ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00400829     History of Changes
Other Study ID Numbers: NCI-2009-01159
NCI-2009-01159 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000514516
PHII-74 ( Other Identifier: City of Hope )
7437 ( Other Identifier: CTEP )
N01CM62204 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
First Submitted: November 16, 2006
First Posted: November 17, 2006
Results First Submitted: December 23, 2014
Results First Posted: January 7, 2015
Last Update Posted: January 7, 2015