Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT00278993

First received: January 17, 2006

Last updated: April 16, 2012

Last verified: April 2012

History of Changes

Results First Received: December 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
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
This study was recruited at 22 centers in U.S, UK, Spain and Hungary during the period of Feb 2006 to May 2009.

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
E7389 Intravenous 1.4 mg/m2	E7389 intravenous 1.4 mg/m2 on a 3-week course

Participant Flow: Overall Study

	E7389 Intravenous 1.4 mg/m2
STARTED	108
COMPLETED	1
NOT COMPLETED	107
Adverse Event	24
Withdrawal by Subject	5
Progressive Disease	65
Physician Decision	9
Not Otherwise Specified	4

Baseline Characteristics

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Reporting Groups

	Description
E7389 Intravenous 1.4 mg/m2	E7389 intravenous 1.4 mg/m2 on a 3-week course

Baseline Measures

	E7389 Intravenous 1.4 mg/m2
Number of Participants [units: participants]	108
Age ^[1] [units: years] Mean ± Standard Deviation	71.0 ± 9.36
Gender [units: participants]
Female	0
Male	108
Race/Ethnicity, Customized [units: participants]
American Indian or Alaska Native	0
Asian	3
Native Hawaiian or Other Pacific Islander	0
Black or African American	6
White	94
More than one race	0
Other	5
Unknown or Not Reported	0

[1]	Intent to Treat/Safety Population

Outcome Measures

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1. Primary:

Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria [ Time Frame: 12 months ]

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2. Secondary:

Duration of Prostate Specific Antigen Response Based on Bubley Criteria [ Time Frame: 12 months. ]

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3. Secondary:

Progression Free Survival [ Time Frame: 12 months ]

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4. Secondary:

Overall Survival [ Time Frame: 12 months ]

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5. Secondary:

Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [ Time Frame: 12 months ]

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Serious Adverse Events

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Other Adverse Events

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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.

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
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Results Point of Contact:

Name/Title: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743

No publications provided

Responsible Party:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00278993 History of Changes
Other Study ID Numbers:	E7389-G000-204
Study First Received:	January 17, 2006
Results First Received:	December 22, 2011
Last Updated:	April 16, 2012
Health Authority:	United States: Food and Drug Administration

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