Text Size

A Dose-Finding Study of E7389 in Combination With Carboplatin in Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00268905
First received: December 21, 2005
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
Results First Received: December 20, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer
Interventions: Drug: E7389 + carboplatin AUC 5
Drug: E7389 + carboplatin AUC 6
Drug: E7389+carboplatin AUC 6

  Participant Flow
  Hide 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
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5 Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6 Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6 Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)

Participant Flow:   Overall Study
    Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5     Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6     Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6  
STARTED     43     9     12  
COMPLETED     0     0     0  
NOT COMPLETED     43     9     12  
Adverse Event                 3                 0                 4  
Lost to Follow-up                 0                 1                 0  
Withdrawal by Subject                 0                 0                 3  
Progressive Disease                 28                 4                 3  
Physician Decision                 3                 0                 1  
Clinical Progression                 9                 4                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5 Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6 Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6 Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
Total Total of all reporting groups

Baseline Measures
    Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5     Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6     Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6     Total  
Number of Participants  
[units: participants]
 		  43     9     12     64  
Age  
[units: years]
Mean ± Standard Deviation 		  59.2  ± 8.35     60.9  ± 8.08     64.4  ± 10.04     60.4  ± 8.75  
Gender  
[units: participants]
 		       
Female     22     5     1     28  
Male     21     4     11     36  
Race (NIH/OMB)  
[units: participants]
 		       
American Indian or Alaska Native     0     0     0     0  
Asian     1     0     0     1  
Native Hawaiian or Other Pacific Islander     0     0     5     5  
Black or African American     14     5     0     19  
White     23     3     7     33  
More than one race     0     0     0     0  
Unknown or Not Reported     5     1     0     6  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of Eribulin Mesylate of E7389 in Combination With Carboplatin in Subjects With Advanced Solid Tumors.   [ Time Frame: 21 days (first cycle) ]
  Show Outcome Measure 1

2.  Secondary:   Safety of Eribulin Mesylate in Combination With Carboplatin as Measured by the Number of Subjects With Treatment Emergent Adverse Events.   [ Time Frame: Throughout the entire study ]
  Show Outcome Measure 2

3.  Secondary:   Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.   [ Time Frame: From start of eribulin treatment until disease progression or death ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.


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.  


Results Point of Contact:  
Name/Title: Prash Krishna, Study Director
Organization: Eisai
phone: 888-422-4743


No publications provided


Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00268905     History of Changes
Other Study ID Numbers: E7389-A001-104
Study First Received: December 21, 2005
Results First Received: December 20, 2012
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration