Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472771
Status:
WITHDRAWN
Last Update Posted:
2012-02-09
First Post:
2007-05-11
Brief Title:
INNO-206 in Patients With Small Cell Lung Cancer SCLC
Sponsor:
CytRx
Organization:
CytRx
Study Overview
Official Title:
A Phase II Open-label Study of INNO-206 in Patients With Recurrent Extensive Small Cell Lung Cancer After First-line Platinum-based Therapy
Status:
WITHDRAWN
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to clinical trial material production delays
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 whether INNO-206 is effective in the treatment of small cell lung cancer
Detailed Description:
This is a phase II open-label prospective multicenter single-arm study of INNO 206 in adult patients with recurrent extensive small cell lung cancer sensitive to first-line platinum-based therapy The primary objective of the study is to determine the objective overall response rate Secondary objectives include evaluating the treatment-related toxicities in this patient population and determining the pharmacokinetic PK profile of INNO-206 in a minimum of 12 patients
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