Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-10 @ 2:08 PM
Study NCT ID:
NCT01963351
Status:
COMPLETED
Last Update Posted:
2014-12-08
First Post:
2013-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab in Combination With Chemotherapy in Patients With Advanced or Recurrent Non-squamous NSCLC
Sponsor:
University of Athens
Organization:
Study Overview
Official Title:
Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2014-12
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 observational trial is designed to assess the safety profile and tolerability of bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC.
Detailed Description:
It is an observational study for the safety and tolerability of the combination of bevacizumab with chemotherapy in locally advanced or metastatic and recurrent non-squamous non-small cell lung cancer. We try to evaluate the safety of bevacizumab in real life population with lung cancer. For patients with performance status 0-1 platinum based chemotherapy was recommended and acceptable doses of bevacizumab was either 7.5 or 15 mg/kgr. Safety profile was evaluated with Common Toxicity criteria v 3.0. Especially for bevacizumab we evaluate specific situations as thrombotic or hemorrhagic events, hypertension, albuminuria, and gastrointestinal disorders.
Study Oversight
Has Oversight DMC:
True
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?: