BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer

Sponsor
Boehringer Ingelheim
Study ID
NCT00904839
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BIBF 1120 — DRUG
    BIBF 1120 100 and 150 mg capsules
  • BIBF 1120 — DRUG
    BIBF 1120 100 and 150 mg capsules
  • mFolfox — DRUG
    standard i.v chemotherapy
  • Bevacizumab — DRUG
    100 mg/Kg solution , IV infusion
  • mFolfox 6 — DRUG
    IV standard chemotherapy
  • bevacizumab — DRUG
    100 mg/4 ml solution

Study Details

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.

Key Dates

First listed
May 20, 2009
Start date
May 31, 2009
Status verified
Feb 2015
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
128 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BIBF 1120 + mFolfox6
    BIBF1120 medium dose twice daily
  • Active Comparator: Bevacizumab + mFolfox6
    Bevacizumab 5mg/kg once daily every other week

Primary Outcome Measure

Progression-free Survival Rate at 9 Months (PFS-9) [ Time Frame: First treatment administration to nine months ]

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