Metastatic colorectal carcinoma MedDRA version: 8.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Interventions
Product Name: BIBF 1120, 50 mg
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: BIBF 1120
Other descriptive name: -
Concentration u
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 years. 2. Histologically proven colorectal adenocarcinoma. 3. Metastatic disease not suitable for curative-intent resection. 4. Measurable (= 1 cm) and evaluable disease (according to RECIST criteria). 5. No prior palliative chemotherapy for metastatic CRC. 6. No prior bevacizumab, cetuximab, Tyrosine Kinase Inhibitos (TKIs). 7. Previous adjuvant therapy with fluoropyrimidines is allowed if disease free survival after the end of chemotherapy is > 6 months. 8. Previous adjuvant therapy with oxaliplatin or irinotecan is allowed if disease free survival after the end of chemotherapy is >12 months. 9. ECOG performance status 0 or 1. 10. Adequate hepatic function. - Total bilirubin within normal range, ALT and AST 1,500/µl. - Platelet count > 100,000/µl. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the trial drugs or their excipients. 2. Treatment with any investigational drug within 28 days of trial onset. 3. Prior treatment with palliative standard chemotherapy for colorectal cancer, prior treatment with either cetuximab, bevacizumab or a tyrosine kinase inhibitor cf. inclusion criteria number 7 and 8). 4. History of other malignancies in the last 5 years, in particular those which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible. 5. Serious concomitant disease, especially those that would limit compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial. 6. Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period. 7. Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure > NYHA II). 8. History of severe haemorrhagic or thrombotic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis). Known inherited predisposition to bleeds or to thrombosis. 9. Patient with brain metastases that are symptomatic and/or require therapy. 10. Patients who require full-dose anticoagulation (INR >2.5). 11. Active alcohol or drug abuse. 12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. abstinence, condom with spermicidal coating, diaphragm with spermicidal coating, oral contraceptive, progesterone implant, sterilisation) during the trial. 13. Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare efficacy and safety of mFOLFOX 7 plus weekly alternating administration of BIBW 2992 and BIBF 1120 versus mFOLFOX 7 in patients with metastatic colorectal cancer.;Secondary Objective: 1. Progression free survival (PFS). 2. Overall survival. 3. Duration of overall response. 4. Secondary operability. 5. Incidence and intensity of adverse events graded according to CTCAE version 3. 6. Pharmakokinetics. ;Primary end point(s): Objective response. | — |
Countries
France, Germany, Spain
Outcome results
None listed