BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Colorectal Neoplasms

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00904839

2008-005364-14 (EudraCT Number)

1199.51

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

BIBF 1120 + mFolfox6

Experimental group

Description:

BIBF1120 medium dose twice daily

Treatment:

Drug: mFolfox 6

Drug: bevacizumab

Drug: BIBF 1120

Drug: BIBF 1120

Bevacizumab + mFolfox6

Active Comparator group

Description:

Bevacizumab 5mg/kg once daily every other week

Treatment:

Drug: Bevacizumab

Drug: BIBF 1120

Drug: mFolfox

Drug: BIBF 1120