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BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer

NCT ID: NCT00904839

Last Updated: 2015-02-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-01-31

Brief Summary

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The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.

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Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIBF 1120 + mFolfox6

BIBF1120 medium dose twice daily

Group Type EXPERIMENTAL

BIBF 1120

Intervention Type DRUG

BIBF 1120 100 and 150 mg capsules

mFolfox 6

Intervention Type DRUG

IV standard chemotherapy

bevacizumab

Intervention Type DRUG

100 mg/4 ml solution

Bevacizumab + mFolfox6

Bevacizumab 5mg/kg once daily every other week

Group Type ACTIVE_COMPARATOR

BIBF 1120

Intervention Type DRUG

BIBF 1120 100 and 150 mg capsules

mFolfox

Intervention Type DRUG

standard i.v chemotherapy

Bevacizumab

Intervention Type DRUG

100 mg/Kg solution , IV infusion

Interventions

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BIBF 1120

BIBF 1120 100 and 150 mg capsules

Intervention Type DRUG

BIBF 1120

BIBF 1120 100 and 150 mg capsules

Intervention Type DRUG

mFolfox

standard i.v chemotherapy

Intervention Type DRUG

Bevacizumab

100 mg/Kg solution , IV infusion

Intervention Type DRUG

mFolfox 6

IV standard chemotherapy

Intervention Type DRUG

bevacizumab

100 mg/4 ml solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age \>= 18 years
2. Histologically proven colorectal adenocarcinoma
3. No previous oxaliplatin based chemotherapy is allowed unless disease free survival after the end of chemotherapy \> = 12 months
4. No previous therapy with VEGFR or EGFR inhibitors
5. No prior systemic therapy for metastatic CRC
6. No previous adjuvant therapy with fluoropyrimidines is allowed unless disease free survival after the end of chemotherapy \> 6 months
7. ECOG performance status \< = 2
8. Adequate hepatic, renal and bone marrow functions:
9. No uncontrolled hypertension
10. Signed and dated written informed consent prior to admission to the study

Exclusion Criteria

1. Treatment with any investigational drug within 28 days of trial onset.
2. History of other malignancies in the last 5 years, in particular those that could affect compliance with the protocol or interpretation of results.
3. Serious concomitant disease, especially those affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug,
4. Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period.
5. Significant cardiovascular diseases
6. History of severe haemorrhagic or thromboembolic event in the past 12 months. Known inherited predisposition to bleeding or to thrombosis.
7. Patient with brain metastases that are symptomatic and/or require therapy.
8. Pregnancy or breast-feeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1199.51.32002 Boehringer Ingelheim Investigational Site

Bonheiden, , Belgium

Site Status

1199.51.32005 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1199.51.32006 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1199.51.32001 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

1199.51.3306A Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1199.51.3306B Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1199.51.3306C Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1199.51.3306D Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1199.51.3301A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1199.51.3301B Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1199.51.3301C Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1199.51.3301D Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1199.51.3307A Boehringer Ingelheim Investigational Site

Reims, , France

Site Status

1199.51.3307B Boehringer Ingelheim Investigational Site

Reims, , France

Site Status

1199.51.3307C Boehringer Ingelheim Investigational Site

Reims, , France

Site Status

1199.51.3308A Boehringer Ingelheim Investigational Site

Saint-Herblain, , France

Site Status

1199.51.3308B Boehringer Ingelheim Investigational Site

Saint-Herblain, , France

Site Status

1199.51.3308C Boehringer Ingelheim Investigational Site

Saint-Herblain, , France

Site Status

1199.51.3308D Boehringer Ingelheim Investigational Site

Saint-Herblain, , France

Site Status

1199.51.3308E Boehringer Ingelheim Investigational Site

Saint-Herblain, , France

Site Status

1199.51.3305A Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1199.51.3305B Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1199.51.3305C Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1199.51.3305D Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1199.51.3305E Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1199.51.3302A Boehringer Ingelheim Investigational Site

Villejuif, , France

Site Status

1199.51.3302B Boehringer Ingelheim Investigational Site

Villejuif, , France

Site Status

1199.51.3302C Boehringer Ingelheim Investigational Site

Villejuif, , France

Site Status

1199.51.3302D Boehringer Ingelheim Investigational Site

Villejuif, , France

Site Status

1199.51.3302E Boehringer Ingelheim Investigational Site

Villejuif, , France

Site Status

1199.51.49001 Boehringer Ingelheim Investigational Site

Celle, , Germany

Site Status

1199.51.49002 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

1199.51.49003 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, , Germany

Site Status

1199.51.49004 Boehringer Ingelheim Investigational Site

Halle, , Germany

Site Status

1199.51.49006 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1199.51.49008 Boehringer Ingelheim Investigational Site

Schwäbisch Hall, , Germany

Site Status

1199.51.39002 Boehringer Ingelheim Investigational Site

Ancona, , Italy

Site Status

1199.51.39001 Boehringer Ingelheim Investigational Site

Genova, , Italy

Site Status

1199.51.39004 Boehringer Ingelheim Investigational Site

Macerata, , Italy

Site Status

1199.51.39005 Boehringer Ingelheim Investigational Site

Reggio Emilia, , Italy

Site Status

1199.51.39003 Boehringer Ingelheim Investigational Site

Udine, , Italy

Site Status

1199.51.34007 Boehringer Ingelheim Investigational Site

A Coruña, , Spain

Site Status

1199.51.34006 Boehringer Ingelheim Investigational Site

Alicante, , Spain

Site Status

1199.51.34005 Boehringer Ingelheim Investigational Site

Barakaldo, , Spain

Site Status

1199.51.34001 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1199.51.34003 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1199.51.34004 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

Countries

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Belgium France Germany Italy Spain

Other Identifiers

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2008-005364-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.51

Identifier Type: -

Identifier Source: org_study_id

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