Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014625
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2001-04-10
Brief Title:
E7070 in Treating Patients With Stage IV Melanoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma Stage IV
Status:
COMPLETED
Status Verified Date:
2012-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma
Detailed Description:
OBJECTIVES I Determine the therapeutic activity of E7070 in terms of objective response duration of response and progression-free survival of patients with metastatic melanoma II Determine the acute side effects of this drug in these patients III Determine the pharmacokinetic parameters of this drug in these patients
OUTLINE This is a multicenter study Patients receive E7070 IV over 1 hour Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks
PROJECTED ACCRUAL A total of 19-24 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive E7070 IV over 1 hour Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks
PROJECTED ACCRUAL A total of 19-24 patients will be accrued for this study
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 |
|---|---|---|---|
| EISAI-E7070-E044-205 | None | None | None |
| EORTC-16005 | None | None | None |
| EORTC-18002 | None | None | None |