Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165880
Status:
TERMINATED
Last Update Posted:
2014-07-01
First Post:
2005-09-13
Brief Title:
An Open-label Randomized Phase II Study of the Efficacy and Safety of Indisulam E7070 in Combination With Capecitabine
Sponsor:
Eisai Limited
Organization:
Eisai Inc
Study Overview
Official Title:
An Open-label Randomized Phase II Study of the Efficacy and Safety of Indisulam E7070 in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Metastatic Breast Cancer Patients Following Prior Anthracycline and Taxane Therapy
Status:
TERMINATED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was stopped prematurely due to lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall purpose of this study is to compare the efficacy safety and tolerability of indisulam in combination with capecitabine IC versus capecitabine C monotherapy in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-000774-31 | EUDRACT_NUMBER | None | None |