Ignite Creation Date:
2024-05-05 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00642824
Status:
TERMINATED
Last Update Posted:
2016-11-02
First Post:
2008-03-19
Brief Title:
A Genetic Substudy Associated With the Avastin Bevacizumab Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Local Substudy Associated to the International Study MO19390 to Determine the BRCA1 Gene mRNA Expression as a Predictive Marker of Response to Chemotherapy
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to low enrollment No statistical analyses were performed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single arm genetic substudy of MO19390 will test the hypothesis that there is a positive relationship between mRNA BRCAI levels and the response to different chemotherapy combinations plus Avastin A subset of patients participating in MO19390 and receiving Avastin 15mgkg iv on day 1 and subsequently once every 3 weeks will undergo BRCAI mRNA expression determination Depending on the BRCAI mRNA level low medium or high they will receive a different chemotherapy regimen in combination with Avastin agemcitabinecisplatin bvinorelbine cisplatindocetaxel cisplatin or cvinorelbine or docetaxel Avastin treatment will continue after completion of chemotherapy cycles until disease progression and the target sample size is 100-500 individuals
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