BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer

NCT00904839 | Completed Phase 2 Results

• 2 other identifiers: 1199.512008-005364-14
• Study Type: interventional
• Target: 128
• Locations: 5 countries
• Sites: 47

Brief Summary

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate at 9 Months (PFS-9)

  PFS-9 is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death. A patient is defined as progression-free for 9 months if their PFS was at least 270 days. Progression is assessed according to following mentioned RECIST criteria (version 1.0). 1. 20% increase in the sum of the longest diameter of target lesions. 2. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

  First treatment administration to nine months

Secondary Outcomes (15)

• Overall Survival

  First treatment administration until end of treatment, up to 892 days

• Progression-free Survival (PFS)

  First treatment administration until end of treatment, up to 892 days

• Confirmed Objective Response Rate

  First treatment administration until end of treatment, up to 892 days

• Unconfirmed Objective Response Rate

  First treatment administration until end of treatment, up to 892 days

• Resection Rate

  First treatment administration until end of treatment, up to 892 days

Study Arms (2)

BIBF 1120 + mFolfox6

EXPERIMENTAL

BIBF1120 medium dose twice daily

Drug: BIBF 1120; Drug: mFolfox 6; Drug: bevacizumab

Bevacizumab + mFolfox6

ACTIVE COMPARATOR

Bevacizumab 5mg/kg once daily every other week

Drug: BIBF 1120; Drug: mFolfox; Drug: Bevacizumab

Interventions

BIBF 1120 DRUG

BIBF 1120 100 and 150 mg capsules

BIBF 1120 + mFolfox6

mFolfox DRUG

standard i.v chemotherapy

Bevacizumab + mFolfox6

bevacizumab DRUG

100 mg/Kg solution , IV infusion

Bevacizumab + mFolfox6

mFolfox 6 DRUG

IV standard chemotherapy

BIBF 1120 + mFolfox6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Treatment with any investigational drug within 28 days of trial onset.
• History of other malignancies in the last 5 years, in particular those that could affect compliance with the protocol or interpretation of results.
• 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,
• Significant cardiovascular diseases
• History of severe haemorrhagic or thromboembolic event in the past 12 months. Known inherited predisposition to bleeding or to thrombosis.
• Patient with brain metastases that are symptomatic and/or require therapy.
• Pregnancy or breast-feeding.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (47)

1199.51.32002 Boehringer Ingelheim Investigational Site

Bonheiden, Belgium

Location

1199.51.32005 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1199.51.32006 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1199.51.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1199.51.3306A Boehringer Ingelheim Investigational Site

Nice, France

Location

1199.51.3306B Boehringer Ingelheim Investigational Site

Nice, France

Location

1199.51.3306C Boehringer Ingelheim Investigational Site

Nice, France

Location

1199.51.3306D Boehringer Ingelheim Investigational Site

Nice, France

Location

1199.51.3301A Boehringer Ingelheim Investigational Site

Paris, France

Location

1199.51.3301B Boehringer Ingelheim Investigational Site

Paris, France

Location

1199.51.3301C Boehringer Ingelheim Investigational Site

Paris, France

Location

1199.51.3301D Boehringer Ingelheim Investigational Site

Paris, France

Location

1199.51.3307A Boehringer Ingelheim Investigational Site

Reims, France

Location

1199.51.3307B Boehringer Ingelheim Investigational Site

Reims, France

Location

1199.51.3307C Boehringer Ingelheim Investigational Site

Reims, France

Location

1199.51.3308A Boehringer Ingelheim Investigational Site

Saint-Herblain, France

Location

1199.51.3308B Boehringer Ingelheim Investigational Site

Saint-Herblain, France

Location

1199.51.3308C Boehringer Ingelheim Investigational Site

Saint-Herblain, France

Location

1199.51.3308D Boehringer Ingelheim Investigational Site

Saint-Herblain, France

Location

1199.51.3308E Boehringer Ingelheim Investigational Site

Saint-Herblain, France

Location

1199.51.3305A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1199.51.3305B Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1199.51.3305C Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1199.51.3305D Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1199.51.3305E Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1199.51.3302A Boehringer Ingelheim Investigational Site

Villejuif, France

Location

1199.51.3302B Boehringer Ingelheim Investigational Site

Villejuif, France

Location

1199.51.3302C Boehringer Ingelheim Investigational Site

Villejuif, France

Location

1199.51.3302D Boehringer Ingelheim Investigational Site

Villejuif, France

Location

1199.51.3302E Boehringer Ingelheim Investigational Site

Villejuif, France

Location

1199.51.49001 Boehringer Ingelheim Investigational Site

Celle, Germany

Location

1199.51.49002 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1199.51.49003 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, Germany

Location

1199.51.49004 Boehringer Ingelheim Investigational Site

Halle, Germany

Location

1199.51.49006 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1199.51.49008 Boehringer Ingelheim Investigational Site

Schwäbisch Hall, Germany

Location

1199.51.39002 Boehringer Ingelheim Investigational Site

Ancona, Italy

Location

1199.51.39001 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1199.51.39004 Boehringer Ingelheim Investigational Site

Macerata, Italy

Location

1199.51.39005 Boehringer Ingelheim Investigational Site

Reggio Emilia, Italy

Location

1199.51.39003 Boehringer Ingelheim Investigational Site

Udine, Italy

Location

1199.51.34007 Boehringer Ingelheim Investigational Site

A Coruña, Spain

Location

1199.51.34006 Boehringer Ingelheim Investigational Site

Alicante, Spain

Location

1199.51.34005 Boehringer Ingelheim Investigational Site

Barakaldo, Spain

Location

1199.51.34001 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1199.51.34003 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1199.51.34004 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

nintedanib; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: May 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 4, 2015
• Results First Posted: February 4, 2015

Record last verified: 2015-02

Locations

IT (5); FR (26); BE (4); ES (6); DE (6)