Gastrointestinal stromal tumor (GIST)
Conditions
Interventions
Regorafenib(160mg)is administered orally once daily
Sponsors
National Cancer Center East Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have been fully informed about the study and have given written consent themselves 2) Patients aged 20 years or older at the time of consent 3) Patients with histologically confirmed metastatic and/or unresectable GIST. 4) Imatinib was discontinued due to disease progression or an adverse event. 5) No prior treatment with Regorafenib or Sunitinib. 6) ECOG Performance Status 0-1 7) Patients able to take oral medications. 8) With measurable lesion according to RECIST ver.1.1.. 9) Adequate organ function a. Hemoglobin >=8.0 g/dL b. Absolute neutrophil count >=1,000 /mm3 c. Platelet count >=100,000 /mm3 d. Total bilirubin <=1.8 mg/dL e. AST and ALT <=100 IU/L f. Serum creatinine <=1.5mg/dL 10) Women of childbearing potential must have a negative pregnancy test within 7days prior to enrollment.Patients who do have intention that uses effective contraception method until 6 months after administering investigational drug. 11) Patient is willing or able to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1) Serious coexisting illness as follows. a. Active double cancer(s) b. CNS metastasis c. Uncontrollable infectious disease d. Uncontrollable pleural effusion, ascites, or cardiac effusion within 2weeks prior to enrollment e. Ileus, renal failure, hepatic failure or cerebrovascular disorder within 6months prior to enrollment f. Interstitial pneumonia or pulmonary fibrosis apparent on CT g. Uncontrolled diabetes mellitus h. Uncontrolled hypertension i.Cardiac infarction, serious or unstable angina or New York Heart Association Class III or IV within 12 months prior to enrollment j Needs antiarrhythmic treatment k. Gastrointestinal bleeding within 4 weeks. l. Positive HBs antigen or HIV antibody m. Need immunosuppressive therapy n. Uncontrolled mental disease or the psychotic manifestation o. Pheochromocytoma 2) Receive the treatment as follows. a.Major surgery therapy within 4 weeks prior to enrollment. b.Chemotherapy (except Imatinib) within 3 weeks prior to enrollment. c. Imatinib within 1 week prior to enrollment. d.Wide field radiotherapy 4 weeks prior to enrollment e.Other investigational drugs within 4 weeks prior to enrollment. 3) Unrecovered AEs related to prior treatment are Grade >= 2 according to CTCAE. 4) Blood transfusion or G-CSF within 14 days prior to enrollment. 5) Gastrointestinal malabsorption 6) Serious renal failure or proteinuria >= 2+ within 7days prior to enrollment 7) Thromboembolic event within 6 months prior to enrollment 8) Untrecovered wound or traumatic fracture 9) Need anticoaglation 10) Women during pregnancy or lactation , 11) Known hypersensitivity to Regorafinib or Regorafinib's excipient 12) Tendency to hemorrhages or Grade >= 3 bleeding within 4 weeks. 13) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival rate at 24weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival:PFS Objective response rate:RR Disease control rate:DCR Clinical effective rate(Objective response or SD persists more than 22weeks.) Adverse event:AE | — |
Countries
Japan
Contacts
Public ContactYoichi Naito
National Cancer Center East Hospital Experimental Therapeutics
Outcome results
None listed