A Genetic Substudy Associated With the Avastin (Bevacizumab) Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

November 1, 2016 updated by: Hoffmann-La Roche

Local Substudy Associated to the International Study MO19390 to Determine the BRCA1 Gene mRNA Expression as a Predictive Marker of Response to Chemotherapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alcorcon, Spain, 28922
      • Alcoy, Spain, 03804
      • Alicante, Spain, 03010
      • Badalona, Spain, 08915
      • Barakaldo, Spain, 48903
      • Burgos, Spain, 09005
      • Elche, Spain, 03203
      • Girona, Spain, 17007
      • Huesca, Spain, 22004
      • La Laguna, Spain, 38320
      • Las Palmas de Gran Canaria, Spain, 35016
      • Lugo, Spain, 27004
      • Madrid, Spain, 28006
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Murcia, Spain, 30008
      • Palma de Mallorca, Spain, 07014
      • Pamplona, Spain, 31008
      • Salamanca, Spain, 37007
      • Valencia, Spain, 46009
      • Valencia, Spain, 41014
      • Zaragoza, Spain, 50009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • participating in, and meeting all inclusion/exclusion criteria of, MO19390.

Exclusion Criteria:

  • not meeting the inclusion/exclusion criteria of MO19390.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Standard chemotherapy
As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.
Drug: bevacizumab [Avastin]
15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Event driven
Event driven

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Throughout study
Throughout study
Overall survival; response rates
Time Frame: Event driven
Event driven

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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