Patients with chemorefractory colorectal cancer MedDRA version: 13.1 Level: LLT Classification code 10052360 Term: Colorectal adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients receiving mFOLFOX6 for histologically proven colorectal adenocarcinoma having received one previous line of chemotherapy 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 1.1 criteria) 5. Only one prior palliative chemotherapy for metastatic CRC 6. Prior bevacizumab permitted 7. No prior TKIs, no prior palliative treatmen twith oxaliplatin 8. Previous adjuvant therapy with an oxaliplatin containing regimen is allowed if the end of adjuvant chemotherapy is > 12 months prior to inclusion into the trial 9. ECOG performance status 0 or 1 10. Adequate hepatic function, renal function, bone marrow function, and lab parameters 11. Life expectancy at least three months 12. Signed and dated written infromed consent prior to admission to the study 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
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 more than one line of palliative standard chemotherapy for colorectal cancer, prior treatment with a tyrosine kinase inhibitor, prior palliative treatment with an oxaliplatin-containing regime. 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 9 months, congestive heart failure > NYHA II). 8. History of severe haemorrhagic or thrombotic events 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. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid = 325mg per day) 11. History of major thrombotic or clinically relevant major bleeding event in the past 6 months 12. Current peripheral neuropathy = CTCAE grade 2 except due to trauma 13. Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy 14. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug 15. Active alcohol or drug abuse. 16. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception 17. Pregnancy or breast-feeding 18. Leptomeningeal disease 19. Radiographic evidence of cavitary or necrotic tumours 20. Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the comparative effectiveness of BIBF 1120 in terms of progression free survival (PFS);Secondary Objective: 1. Objective response 2. Overall survival 3. Duration of overall response 4. Incidence and intensity of adverse events graded according to CTC AE version 3 5. Explorative analysis of predictive biomarkers for BIBF 1120 ;Primary end point(s): This trial is designed with the primary endpoint of progression free survival (PFS).;Timepoint(s) of evaluation of this end point: The final anaysis will be conducted when 145 randomized patients have died or experienced progressive disease. This is expected to take approximately two years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint is objective response (either complete or partial). ;Timepoint(s) of evaluation of this end point: The final anaysis will be conducted when 145 randomized patients have died or experienced progressive disease. | — |
Countries
Germany
Contacts
Public ContactDr. Jürgen E. Metzner
Galmed GmbH
Outcome results
None listed