Trial information
A Genetic Substudy Associated With the Avastin (Bevacizumab) Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Status: No longer recruiting
Protocol number: ML21150
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Local substudy associated to the international study MO19390 to determine the BRCA1 gene mRNA expression as a predictive marker of response to chemotherapy
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. Target sample size is
40.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Progression-free survival Time frame: Event driven
Key secondary outcomes: 1. Overall survival; response rates Time frame: Event driven
2. Adverse events Time frame: Throughout study
Inclusion criteria:
- participating in, and meeting all inclusion/exclusion criteria of, MO19390.
Exclusion criteria:
- not meeting the inclusion/exclusion criteria of MO19390.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2007
Trial registration date: 03/18/2008
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Spain
- Alcorcon
- Alicante
- Badalona
- Barakaldo
- Girona
- Huesca
- La Laguna
- Las Palmas de Gran Canaria
- Lugo
- Madrid
- Murcia
- Palma de Mallorca
- Pamplona
- Salamanca
- Valencia
- Zaragoza
