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BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer

NCT00904839 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2015-02-04

Study results available
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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

Interventions

DRUG

BIBF 1120

BIBF 1120 100 and 150 mg capsules

DRUG

BIBF 1120

BIBF 1120 100 and 150 mg capsules

DRUG

mFolfox

standard i.v chemotherapy

DRUG

Bevacizumab

100 mg/Kg solution , IV infusion

DRUG

mFolfox 6

IV standard chemotherapy

DRUG

bevacizumab

100 mg/4 ml solution

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00904839 on ClinicalTrials.gov