Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101413
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2005-01-10
Brief Title:
BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma NSCLC
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Patients With Relapsed or Refractory Advanced Non-small Cell Lung Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-09
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:
The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors how long the effect continues if the patients receiving BAY43-9006 will live longer
If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer
If BAY43-9006 helps to slow the worsening of non-small cell lung cancer
If BAY43-9006 prevents the growth of or shrinks non-small cell lung tumors andor their metastases
If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer
If BAY43-9006 helps to slow the worsening of non-small cell lung cancer
If BAY43-9006 prevents the growth of or shrinks non-small cell lung tumors andor their metastases
Detailed Description:
In addition to the key secondary outcome parameters several potential biomarkers were evaluated as exploratory parameters
Issues on safety are addressed in the Adverse Event section
The following acronyms and abbreviations were used in the Adverse Event section and Limitations and Caveats section
gastrointestinal GI
not otherwise specified NOS
central nervous system CNS
National Cancer Institute Common Terminology Criteria NCI-CTC
Medical Dictionary for Regulatory Activities MedDRA
System Organ Class SOC
interim analysis IA
Issues on safety are addressed in the Adverse Event section
The following acronyms and abbreviations were used in the Adverse Event section and Limitations and Caveats section
gastrointestinal GI
not otherwise specified NOS
central nervous system CNS
National Cancer Institute Common Terminology Criteria NCI-CTC
Medical Dictionary for Regulatory Activities MedDRA
System Organ Class SOC
interim analysis IA
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