Metastatic Solid Tumors MedDRA version: 17.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Stivarga 40 mg
Product Name: Stivarga
Product Code: Bay 73-4506
Pharmaceutical Form: Coated tablet
INN or Proposed INN: regorafenib
CAS Number: 755037-03-7
Other descriptive name: REGORAFE
Sponsors
Istituto Clinico Humanitas
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Patients 1. Signed informed consent 2. Patients = 18 years. 3. Locally advanced, recurrent or metastatic histologically confirmed malignancy refractory to available standard treatment, included in the list below - Pancreatic cancer - Ovarian cancer - Melanoma - Sarcoma (angiosarcoma, leiomyosarcoma e sinovial sarcoma) 4. At least one measurable lesion according to Response Evaluation Criteria In Solid Tumor (RECIST criteria, Version 1.1) (see Appendix C). Lesions must be measured by CT-scan or MRI 5. ECOG Performance Status: 0-1 6. Life expectancy of at least 12 weeks 7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: - Hemoglobin >9.0 g/dl - Absolute neutrophil count (ANC) >1,500/mm3 - Platelet count = 100,000/µl - WBC >3.0 x 109/L - Total bilirubin 30ml/min as calculated using the Crockcroft-Gault equation 10. Resolution of any toxic effects of prior therapy to NCI CTCAE, Version 4.0, grade = 1 (with the exception of alopecia and grade = 2 neuropathy) . 11. Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug admnistration. The investigator or a designated associate is requested to advise the subject on how to achieve an adequate birth control. Adequate contraceptions is definde in the study as medically recommended method ( or combination of methods) as per standard care.18 years. 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior treatment with regorafenib. 2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug 3. Congestive heart failure >New York Heart Association (NYHA) class 2 4. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months).Myocardial infarction less than 6 months before start of study drug 5. Myocardial infarction less than 6 months before start of study drug. 6. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) 7. Uncontrolled hypertension. (Systolic blood pressure >150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management) 8. Pleural effusion or ascites that causes respiratory compromise (>CTCAE Grade 2 dyspnea). 9. Ongoing infection > Grade 2 CTCAE v. 4.0. 10. Known history of human immunodeficiency virus (HIV) infection. 11. Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy. 12. Subjects with seizure disorder requiring medication. 13. History of organ allograft. Subjects with evidence orzhistory of any bleeding diathesis, irrespective of severity. 14. Any hemorrhage or bleeding event >CTCAE Grade 3 within 4 weeks prior to the start of study medication. 15. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occuring more than one months before the start of study medication) 16. Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms 17. Suggestive or consistent with CNS disease)Non-healing wound, ulcer, or bone fracture. 18. Renal failure requiring hemo-or peritoneal dialysis. 19. Dehydration CTCAE v. 4.0 Grade >1. 20. Substance abuse, medical, psychological or social conditions that may interfere with the subject?s participation in the study or evaluation of the study results. 21. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. 22. Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his/her compliance in the study. 23. Interstitial lung disease with ongoing signs and symptoms 24. Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours). 25. Any malabsorption condition. 26. Concomitant participation or participation within the last 30 days in another clinical trial 27. Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Estimate Progression -free survival (PFS) from disease;Secondary Objective: Estimate overall Survival (OS) Estimate Rate of Tumor response (ORR) Evaluate Regorafenib Safety;Primary end point(s): 2 Month PFS rate;Timepoint(s) of evaluation of this end point: October 2018 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Estimate overall Survival (OS) Estimate Rate of Tumor response (ORR) Evaluate Regorafenib Safety;Timepoint(s) of evaluation of this end point: May 2019 | — |
Countries
Italy
Contacts
Public ContactCRO
EMMEDI Srl Divisione Solaris
Outcome results
None listed