Study Stopped
Terminated due to low enrollment. No statistical analyses were performed.
A Genetic Substudy Associated With the Avastin (Bevacizumab) Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Local Substudy Associated to the International Study MO19390 to Determine the BRCA1 Gene mRNA Expression as a Predictive Marker of Response to Chemotherapy
1 other identifier
interventional
3
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2007
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedNovember 2, 2016
November 1, 2016
2.6 years
March 19, 2008
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
Event driven
Secondary Outcomes (2)
Overall survival; response rates
Event driven
Adverse events
Throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Alcorcón, 28922, Spain
Unknown Facility
Alcoy, 03804, Spain
Unknown Facility
Alicante, 03010, Spain
Unknown Facility
Badalona, 08915, Spain
Unknown Facility
Barakaldo, 48903, Spain
Unknown Facility
Burgos, 09005, Spain
Unknown Facility
Elche, 03203, Spain
Unknown Facility
Girona, 17007, Spain
Unknown Facility
Huesca, 22004, Spain
Unknown Facility
Las Palmas de Gran Canaria, 35016, Spain
Unknown Facility
Lugo, 27004, Spain
Unknown Facility
Madrid, 28006, Spain
Unknown Facility
Madrid, 28040, Spain
Unknown Facility
Madrid, 28046, Spain
Unknown Facility
Murcia, 30008, Spain
Unknown Facility
Palma de Mallorca, 07014, Spain
Unknown Facility
Pamplona, 31008, Spain
Unknown Facility
Salamanca, 37007, Spain
Unknown Facility
San Cristóbal de La Laguna, 38320, Spain
Unknown Facility
Valencia, 41014, Spain
Unknown Facility
Valencia, 46009, Spain
Unknown Facility
Zaragoza, 50009, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 25, 2008
Study Start
May 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
November 2, 2016
Record last verified: 2016-11