Study of E7389 in Patients With Advanced Solid Tumors

This study has been completed.

Study NCT00069264 Information provided by Eisai Inc.

First Received on September 19, 2003. Last Updated on November 16, 2011 History of Changes

Results First Received: November 16, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Advanced Solid Tumors
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
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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	E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.

Participant Flow: Overall Study

	E7389
STARTED	32
COMPLETED	0
NOT COMPLETED	32
Adverse Event	3
Progressive Disease	23
Withdrawal by Subject	3
Discon Therapy	3

Baseline Characteristics

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Reporting Groups

	Description
E7389	E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.

Baseline Measures

	E7389
Number of Participants [units: participants]	32
Age [units: years] Mean ± Standard Deviation	57.4 ± 11.29
Gender [units: participants]
Female	21
Male	11
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	8
Not Hispanic or Latino	24
Unknown or Not Reported	0
Race (NIH/OMB) ^[1] [units: Participants]
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	7
White	16
More than one race	0
Unknown or Not Reported	8
Region of Enrollment [units: participants]
United States	32

[1]	Please note: 8 subjects in unknown category were Hispanic/Latino

Outcome Measures

1. Primary:

Determination of the Maximum Tolerated Dose [ Time Frame: 28 Days ]

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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: Dr. Peter Tarassoff
Organization: Eisai Inc.
phone: 888-422--4743

No publications provided

ClinicalTrials.gov Identifier:	NCT00069264 History of Changes
Other Study ID Numbers:	E7389-A001-101, E7389, BOLD
Study First Received:	September 19, 2003
Results First Received:	November 16, 2011
Last Updated:	November 16, 2011
Health Authority:	United States: Food and Drug Administration