Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT00059735
Status:
COMPLETED
Last Update Posted:
2008-03-05
First Post:
2003-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety, Tolerability and Efficacy Study of E7070 in Patients With Renal Cell Carcinoma
Sponsor:
Eisai Inc.
Organization:
Study Overview
Official Title:
A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC)
Status:
COMPLETED
Status Verified Date:
2008-02
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 E7070 is a safe and effective treatment for cancer of the kidneys.
Detailed Description:
Renal Cell Carcinoma (RCC) accounts for approximately 2% of all cancers and its incidence is increasing with worldwide deaths of over 100,000 patients per year. About 50% of RCC patients have inoperable or metastatic disease that surgery cannot be performed on. RCC is also considered to be resistant to both radiotherapy and cytotoxic chemotherapy. The purpose of this study is to evaluate the safety and effectiveness of E7070 by assessing progression free survival, tumor response rate, duration of response/stable disease, and survival time. E7070 will be administered as a single iv infusion over 60 minutes on Day 1 of each cycle. Patients will continue treatment with E7070 until they no longer have clinical benefit and have disease progression, or toxicity leads to patient withdrawal.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: