Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097721
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2004-11-29
Brief Title:
A Study of E7389 in AdvancedMetastatic Breast Cancer Patients
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase II Open Label Study of E7389 Halichondrin B Analog in Patients With AdvancedMetastatic Breast Cancer Previously Treated With Chemotherapy Including An Anthracycline and A Taxane
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if E7389 is a safe and effective treatment for advancedmetastatic breast cancer
Detailed Description:
The primary objective is to determine the response rate RR to E7389 monotherapy administered as an IV bolus of 14 mgm2 on Days 1 8 and 15 of a 28-Day cycle and on Days 1 and 8 of a 21-day cycle in patients with advancedmetastatic breast cancer treated with chemotherapy including an anthracycline and a taxane with previously documented progression during or within six months following the last dose of prior chemotherapy
The secondary objectives are to evaluate
The safety and tolerability of E7389 monotherapy in this patient population
The antitumor activity of E7389 as determined by duration of response time to progression and overall survival
Quality of life measured by the Functional Assessment of Cancer Therapy-Breast FACT-B questionnairetumor-related symptom improvement or worsening measured by pain intensity on a visual analog scale VAS analgesics consumption weight changes and performance status PS
Tumor pharmacogenetics and their possible relationship to response assessment of beta-tubulin isotype mRNA on biopsy sample in patients who have signed a separate consent form
The secondary objectives are to evaluate
The safety and tolerability of E7389 monotherapy in this patient population
The antitumor activity of E7389 as determined by duration of response time to progression and overall survival
Quality of life measured by the Functional Assessment of Cancer Therapy-Breast FACT-B questionnairetumor-related symptom improvement or worsening measured by pain intensity on a visual analog scale VAS analgesics consumption weight changes and performance status PS
Tumor pharmacogenetics and their possible relationship to response assessment of beta-tubulin isotype mRNA on biopsy sample in patients who have signed a separate consent form
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None