Non-Squamous Non-Small Cell Lung Cancer Clinical Trial
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
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - participating in, and meeting all inclusion/exclusion criteria of, MO19390. Exclusion Criteria: - not meeting the inclusion/exclusion criteria of MO19390. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | Event driven | No | |
Secondary | Overall survival; response rates | Event driven | No | |
Secondary | Adverse events | Throughout study | No |
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