Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274443
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2006-01-10
Brief Title:
An Open Label Study in Patients With Advanced NSCLC With ABI-007Abraxane in Combination With Carboplatin
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
An Open -Label Phase II Trial of Increasing Doses of ABI-007 and Carboplatin in Patients With Advanced Non Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2019-11
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:
This is an open-label dose escalation trial using ABI-007 plus carboplatin
Detailed Description:
This is a multicenter study conducted at study sites in Russia and the Ukraine where various doses of ABI-007 Abraxane will be given in combination with carboplatin to patients with non-small cell lung cancer to determine the recommended dose and schedule for this combination therapy for Phase III trials The primary objective of this study is to obtain preliminary information on the antitumor activity and adverse events of ABI-007 in combination with carboplatin
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