Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085826
Status:
COMPLETED
Last Update Posted:
2011-10-20
First Post:
2004-06-15
Brief Title:
A Phase III Study of the Efficacy of TaxotereAptosyn Versus TaxoterePlacebo in Non-Small Cell Lung Cancer Patients
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase III Randomized Double-Blind Multi-Center Study of the Efficacy of Taxotere Docetaxel in Combination With Aptosyn Exisulind Versus Taxotere Docetaxel and Placebo in Non-Small Cell Lung Cancer NSCLC Patients After Failure of Prior Platinum-Based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens The main purpose of this research study is to determine if Aptosyn when given in combination with Taxotere will result in prolonged survival when compared to Taxotere alone
This study will also help determine tumor response rates and the safety profile of Aptosyn in combination with Taxotere
This study has been completed and a publication is pending
This study will also help determine tumor response rates and the safety profile of Aptosyn in combination with Taxotere
This study has been completed and a publication is pending
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