BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Colorectal Neoplasms	Drug: BIBF 1120 Drug: mFolfox Drug: Bevacizumab Drug: mFolfox 6 Drug: bevacizumab	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I-II Study of BIBF 1120 and FOLFOX Compared to Bevacizumab and FOLFOX in First Line Metastatic Colorectal Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary endpoint of the phase II part is the 9 month PFS rate in BIBF 1120 combined with mFolfox6 in comparison to bevacizumab combined with mFolfox6. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy of BIBF1120 based on OS, PFS, Overall response rate, resection rate and tumour shrinkage [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Appropriate dose of BIBF 1120 in the first 12 to 18 patients when combined with mFolfox6 [ Time Frame: 2 weeks (cycle duration for DLT determination) ] [ Designated as safety issue: No ]
Safety assessed by the evaluation of the incidence and intensity of adverse events with grading according to the US NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0) [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
Pharmacokinetics characteristics of BIBF 1120, 5-FU and oxaliplatin [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
Quality of life evaluation by the standardised questionnaires European Organization for Research and Treatment of Cancer Quality of Life Questionnaire ( EORTC-QLQ-C30) and Colorectal Cancer-Specific Quality of Life Questionnaire (EORTC-QLQ-CR38) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
Biomarkers analysis including Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor (FGF), Platelet- Derived Growth Factor (PDGF) plasma levels, Genetic variation, oncogene profile) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Enrollment:	128
Study Start Date:	May 2009
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BIBF 1120 + mFolfox6 BIBF1120 medium dose twice daily	Drug: BIBF 1120 BIBF 1120 100 and 150 mg capsules Drug: mFolfox 6 IV standard chemotherapy Drug: bevacizumab 100 mg/4 ml solution
Active Comparator: Bevacizumab + mFolfox6 Bevacizumab 5mg/kg once daily every other week	Drug: BIBF 1120 BIBF 1120 100 and 150 mg capsules Drug: mFolfox standard i.v chemotherapy Drug: Bevacizumab 100 mg/Kg solution , IV infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

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

Exclusion criteria:

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,
Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904839

Show 47 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00904839 History of Changes
Other Study ID Numbers:	1199.51, 2008-005364-14
Study First Received:	May 18, 2009
Last Updated:	June 27, 2012
Health Authority:	Belgium: Federal Agency for Medicinal and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: Ethics Committee Spain: Spanish Agency of Medicines United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013