unresectable metastatic colorectal cancer
Conditions
Interventions
Regorafenib 40 mg tablets Regorafenib 120 mg od po. 3weeks on/1 week off Patients will continue study treatment until disease progression
Sponsors
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent. 2) Male or female patients >= 20 3) Historical or cytological documentation of adenocarcinoma of the colon or rectum 4) Progress during or within 3 month following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab. 5) Patients must have measurable or non measurable disease according to RECIST version 1.1 6) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 7) Life expectancy of at least 3 months. 8) Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements conducted within 14 days of starting study treatment: 1. Absolute neutrophil count >= 1500 /mm3 2. Hemoglobin >= 9.0 g/dl 3. Platelet >=100000 /mm3 4. Total bilirubin <=1.5 ml/dl 5. AST and ALT <=150 IU/l 6. Creatinine <= 1.5 mg/dl
Exclusion criteria
Exclusion criteria: 1) Prior treatment with regorafenib. 2) Previous or concurrent cancer that is distinct in primary site or histology form colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervicalcancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta, Tis and T1]. 3) Major surgical procedure within 28 days before start of study medication. 4) Pregnant or breast-feeding patients. Woman of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment. 5)Congestive heart failure >=NYHA class 2. 6) Unstable angina, new-onset angina. Myocardial infarction less than 6 months before start of study medication. 7)Uncontrolled hypertension. 8) Pleural effusion or ascites with dyspnea higher than CTCAE v4.0 grade 2. 9) Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication. 10) Known history of HIV infection, or chronic hepatitis B or C. 12) Symptomatic metastatic brain or meningeal metastasis. 13) Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >= CTCAE v4.0 Grade 3 within 4 weeks of start of study medication. 14) Interstitial lung disease with ongoing sings and symptoms at the time of informed consent. 15) Persistant proteinuria of CTCAE v4.0 Grade 3 or higher. 16) Patients unable to swallow oral medications. 17) Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. 18) Non-healing wound, ulcer, or bone fracture. 19) Unsolved toxicity higher than CTCAE v4.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity <= Grade 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, Response rate, Safety, Drug compliance (Dose intensity) | — |
Countries
Japan
Contacts
Public ContactToshihiro Kudo
Graduate School of Medicine Osaka University Department of Frontier Science for Cancer and Chemotherapy
Outcome results
None listed