Metastatic colorectal cancer MedDRA version: 16.0 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Regorafenib
Product Code: BAY 73-4506
Pharmaceutical Form: Tablet
INN or Proposed INN: Regorafenib
CAS Number: 755037-03-7
Current Sponsor code: BAY 73-4506
Other descriptive name: REGOR
Sponsors
Grupo de Tratamiento de los Tumores Digestivos (TTD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signing of the informed consent form. 2. The patient must be able to understand the information and state expressly his or her desire to take part in the study. 3. Age > 18 years. 4. Patients with histologically or cytologically documented adenocarcinoma of the colon or rectum who have not been previously treated systemically for advanced disease. Patients can have received fluoropyrimidine-based adjuvant therapy if the last dose was taken at least 6 months prior to study entry. 5. Patients who are frail and/or unfit for polychemotherapy owing to the presence of one or more of the following criteria: a. Patients with dependence in activities of daily living owing to the presence of comorbidities other than those resulting from the deterioration caused by the neoplastic disease. b. Presence in the patient's medical history of three or more of the following comorbidities, even if they are under control with proper treatment: - Congestive heart failure - Other chronic cardiovascular diseases - Chronic obstructive pulmonary disease - Cerebrovascular disease - Peripheral neuropathy - Chronic kidney failure (creatinine clearance >30 mL/min) - Hypertension - Diabetes mellitus - Systemic vasculitis - Severe arthritis c. Presence of geriatric syndromes such as age > 85 years, faecal or urinary incontinence, spontaneous bone fractures, mild and moderate dementia, or patients who fall repeatedly. 6. Existence of at least one measurable unidimensional lesion using CT or MRI based on the RECIST criteria, version 1.1 7. Overall Eastern Cooperative Oncology Group (ECOG) performance less than or equal to 2 8. Patient's commitment to compliance with the oral medication throughout the duration of the study 9. Life expectancy of at least 3 months 10. Adequate bone marrow, renal and hepatic function, defined as: a. Neutrophils >1500/mm3 b. Platelets >100,000/mm3 c. Haemoglobin = 9,0 g/dL d. Creatinine clearance > 30 ml/min e. Bilirubin levels =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1. Prior treatment with regorafenib. 2. Assignment prior to the treatment during this study. Patients who are permanently withdrawn from participation in the study treatment will not be allowed to return to it. 3. Prior or concurrent presence of another neoplastic disease that is different in terms of tumour site and histology of the colorectal cancer in the 5 years prior to the inclusion of the patient in the study, except in situ cervical cancer, superficial bladder carcinoma [Ta (non-invasive), Tis (carcinoma in situ) and T1 (tumour invades lamina propria)] and non-melanoma skin tumours. 4. Presence or history of brain metastases or meningeal tumours. 5. Major surgery, open biopsy or traumatic injury within 28 days prior to the start of patient treatment with the study medication. 6. Extended-field radiotherapy within 4 weeks prior to randomisation or limited-field radiotherapy in the previous 2 weeks. Patients must have recovered from all treatment-related toxicities. 7. Pregnant or breast-feeding women. Women of childbearing age must use adequate contraception. Women of childbearing age must have a negative pregnancy test within 7 days prior to starting with the study medication. 8. Women of childbearing age and men who wish to take part in the study must agree to use adequate contraception from the signing of the informed consent until at least 3 months after stopping the study medication. The investigator or the person designated by him or her will ensure and advise as to the contraceptive methods that should be used. Appropriate contraceptive methods include abstinence, oral contraceptives, transdermal patches and injections of sustained-release progestin (starting at least 4 weeks before administration of the IMP), double-barrier method: condom or female condom (diaphragm or cervical/vaginal condom) plus spermicide, intrauterine device (IUD), intrauterine system, implant or vaginal ring (in place at least 4 weeks before administration of the IMP) or male partner sterilisation (vasectomy with documentation of azoospermia) prior to inclusion of the woman in the trial if he is the woman's only sexual partner. 9. Active congestive heart failure class 2 or higher on the NYHA scale (New York Heart Association). 10. Unstable angina (angina symptoms at rest), new-onset angina (having appeared in the past 3 months) or acute myocardial infarction that has occurred in the 6 months prior to starting with the study medication. 11. Cardiac arrhythmias that require anti-arrhythmic therapy (only beta blockers and digoxin would be allowed as concomitant medication for these patients). 12. Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg) despite proper medical management. 13. Patients with phaeochromocytoma. 14. Pleural effusion or ascites that cause breathing difficulties (dyspnoea of grade ? 2 of the CTC). 15. Venous or arterial thromboembolism or embolic events such as cerebrovascular accidents (including transient ischaemic attacks), deep vein thrombosis or pulmonary thromboembolism that have occurred in the 6 months prior to starting with the study medication. 16. Active infection > grade 2 based on the NCI CTC, v. 4.0. 17. Human immunodeficiency virus (HIV) infection. 18. Active hepatitis B or C, or hepatitis B or C infection that requires treatment with antiviral drugs. 19. Patients with severe mental disorders that require medication. 20. History of organ transpl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of single-agent regorafenib in terms of progression-free survival at 6 months.;Secondary Objective: - To assess the safety and tolerability of regorafenib. - To assess objective response rate, - To assess disease control rate, - To assess response duration, - To assess time to response, - To assess time to disease progression, - To assess time to treatment failure, - To assess duration of stable disease, - To assess progression free survival, - To assess overall survival.;Primary end point(s): 6 months progression free survival;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: 1- Objective response rate 2- Disease control rate 3- Time to response 4- Time to progression 5- Progression-free survival 6- Time to treatment failure 7- Response duration 8- Duration of stable disease 9- Progression free survival 10- Overall survival Safety: 1- Incidence and severity of AEs (NCI CTC, version 4.0) 2- Changes in laboratory values 3- Change in vital signs 4- Incidence of dose-adjustments and compliance 5- Incidence of concomitant medication 6- Changes in ECOG performance status over time from baseline.;Timepoint(s) of evaluation of this end point: Eficacy: 1- end of treatment 2- end of treatment 3- first documented response 4- end of treatment 5- end of treatment 6- end of treatment 7- end of treatment 8- end of treatment 9- progression disease 10- death Safety: 1- end of treatment 2- end of treatment 3- end of treatment 4- end of treatment 5- end of treatment 6- end of treatment | — |
Countries
Spain
Contacts
Public ContactTTD
Grupo de Tratamiento de los Tumores Digestivos (TTD)
Outcome results
None listed