A phase I-II study of BIBF 1120 and Folfox compared to Bevacizumab and Folfox in first line metastatic colorectal cancer patients. - BIBF 1120 vs Bevacizumab in CRC

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005364-14-BE

Enrollment

120

Registered

2009-02-27

Start date

2009-06-03

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic colorectal cancer MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer

Interventions

Product Code: BIBF 1120 100mg Pharmaceutical Form: Capsule, soft Current Sponsor code: BIBF 1120 100 mg Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Produc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age >= 18 years - Histologically proven colorectal adenocarcinoma - No previous oxaliplatin based chemotherapy unless disease free survival after the end of chemotherapy is >= 12 months - No previous therapy with VEGFR or EGFR inhibitors - No prior systemic therapy for metastatic CRC - No previous adjuvant therapy with fluoropyrimidines unless disease free survival after the end of chemotherapy is >= 6 months - ECOG performance status ==65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Known hypersensitivity to the trial drugs or their excipients - Treatment with any investigational drug within 28 days of trial onset - History of other malignancies in the last 5 years - Serious concomitant disease - Major injuries and /or bone fracture within 4 weeks of trial inclusion or planned surgical procedures during the trial period - Significant cardiovascular disease - History of severe haemorrhagic or thromboembolic event in the past 12 months - Patient who require full-dose anticoagulation (INR>2.5) - Pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared to mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.;Secondary Objective: - Efficacy of BIBF 1120: overall survival, PFS, Overall response rate, resection rate and tumour shrinkage - Safety - Pharmacokinetic - Quality of life - Biomarkers analysis (VEGF, FGF, PDGF plasma levels, oncogene profile);Primary end point(s): The primary enpoint will assess: The efficacy through 9 months-PFS rate	—

Measure

Time frame

Main Objective: The primary objective of this trial is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared to mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.;Secondary Objective: - Efficacy of BIBF 1120: overall survival, PFS, Overall response rate, resection rate and tumour shrinkage - Safety - Pharmacokinetic - Quality of life - Biomarkers analysis (VEGF, FGF, PDGF plasma levels, oncogene profile);Primary end point(s): The primary enpoint will assess: The efficacy through 9 months-PFS rate

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Countries

Belgium, France, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026