Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051571
Status:
COMPLETED
Last Update Posted:
2011-10-24
First Post:
2003-01-13
Brief Title:
SafetyEfficacy Study of Immunoconjugate With Docetaxel in Non-small Cell Lung Carcinoma
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase II Study Using SGN-15 cBR96-Doxorubicin Immunoconjugate in Combination With Docetaxel for the Treatment of Advanced Stage or Recurrent Non-Small Cell Lung Carcinoma
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:
This randomized phase II clinical trial evaluates the combination of a monoclonal antibody-based drug SGN-15 with a chemotherapeutic agent compared to chemotherapy given alone in patients with non-small cell lung cancer that has failed at least one prior systemic therapy The objective of the study is to determine the safety and clinical benefit as measured by tumor response and quality of life to the combination regimen
Monoclonal antibody therapy has been used in other types of cancer to target therapy to the tumor thereby allowing for the chemotherapeutic agent to have a lesser effect on normal healthy tissue
Monoclonal antibody therapy has been used in other types of cancer to target therapy to the tumor thereby allowing for the chemotherapeutic agent to have a lesser effect on normal healthy tissue
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