Phase I Clinical Study of E7389
This study has been completed.
Sponsor:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00326950
First received: May 16, 2006
Last updated: March 6, 2012
Last verified: March 2012
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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: |
Cancer |
| Intervention: |
Drug: E7389 |
Participant Flow
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 1 center in Japan during the period of May 2006 to Jan 2008 |
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 | |
|---|---|
| E7389 | E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2. |
Participant Flow: Overall Study
| E7389 | |
|---|---|
| STARTED | 15 |
| COMPLETED | 14 |
| NOT COMPLETED | 1 |
| Progressive Disease | 1 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| E7389 | E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2. |
Baseline Measures
| E7389 | |
|---|---|
|
Number of Participants
[units: participants] |
15 |
|
Age
[units: years] Mean ± Standard Deviation |
58.1 ± 7.9 |
|
Gender
[units: participants] |
|
| Female | 6 |
| Male | 9 |
|
Race (NIH/OMB)
[1] [units: 15] |
|
| American Indian or Alaska Native | 0 |
| Asian | 15 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
|
Region of Enrollment
[units: participants] |
|
| Japan | 15 |
| [1] | Subjects were Japanese |
|---|
Outcome Measures
| 1. Primary: | Number of Subjects Who Experienced Dose Limiting Toxicity (DLT) [ Time Frame: 3 weeks ] |
| 2. Primary: | Maximum Tolerated Dose (MTD) [ Time Frame: 3 Weeks ] |
| 3. Secondary: | Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects. [ Time Frame: 3 weeks ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
Yes
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743
Organization: Eisai Call Center
phone: 888-422-4743
No publications provided
| Responsible Party: | Eisai Inc. ( Eisai Co., Ltd. ) |
| ClinicalTrials.gov Identifier: | NCT00326950 History of Changes |
| Other Study ID Numbers: | E7389-J081-105 |
| Study First Received: | May 16, 2006 |
| Results First Received: | November 16, 2011 |
| Last Updated: | March 6, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |