Back to resultsA Genetic Substudy Associated With the Avastin (Bevacizumab) Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Standard chemotherapy
bevacizumab [Avastin]
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- participating in, and meeting all inclusion/exclusion criteria of, MO19390.
Exclusion Criteria:
- not meeting the inclusion/exclusion criteria of MO19390.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Overall survival; response rates
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00642824
Brief Title
A Genetic Substudy Associated With the Avastin (Bevacizumab) Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low enrollment. No statistical analyses were performed.
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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 15mg/kg 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: a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 100-500 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Standard chemotherapy
Intervention Description
As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Event driven
Secondary Outcome Measure Information:
Title
Overall survival; response rates
Time Frame
Event driven
Title
Adverse events
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participating in, and meeting all inclusion/exclusion criteria of, MO19390.
Exclusion Criteria:
not meeting the inclusion/exclusion criteria of MO19390.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
City
Alcoy
ZIP/Postal Code
03804
Country
Spain
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Badalona
ZIP/Postal Code
08915
Country
Spain
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
City
Burgos
ZIP/Postal Code
09005
Country
Spain
City
Elche
ZIP/Postal Code
03203
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
Huesca
ZIP/Postal Code
22004
Country
Spain
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
City
Lugo
ZIP/Postal Code
27004
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Murcia
ZIP/Postal Code
30008
Country
Spain
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Valencia
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Genetic Substudy Associated With the Avastin (Bevacizumab) Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
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