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

NCT ID: NCT00642824

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Squamous Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Standard chemotherapy

Intervention Type DRUG

As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.

bevacizumab [Avastin]

Intervention Type DRUG

15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks

Interventions

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Standard chemotherapy

As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.

Intervention Type DRUG

bevacizumab [Avastin]

15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

* not meeting the inclusion/exclusion criteria of MO19390.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Alcorcón, , Spain

Site Status

Alcoy, , Spain

Site Status

Alicante, , Spain

Site Status

Badalona, , Spain

Site Status

Barakaldo, , Spain

Site Status

Burgos, , Spain

Site Status

Elche, , Spain

Site Status

Girona, , Spain

Site Status

Huesca, , Spain

Site Status

Las Palmas de Gran Canaria, , Spain

Site Status

Lugo, , Spain

Site Status

Madrid, , Spain

Site Status

Madrid, , Spain

Site Status

Madrid, , Spain

Site Status

Murcia, , Spain

Site Status

Palma de Mallorca, , Spain

Site Status

Pamplona, , Spain

Site Status

Salamanca, , Spain

Site Status

San Cristóbal de La Laguna, , Spain

Site Status

Valencia, , Spain

Site Status

Valencia, , Spain

Site Status

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ML21150

Identifier Type: -

Identifier Source: org_study_id