Gastrointestinal Stromal Tumour (GIST)
Conditions
Brief summary
The main purpose of this study is to examine whether regorafenib treatment can help people with gastrointestinal stromal tumours (GIST) and have gene mutation on c-kit exon 17. The safety of regorafenib treatment is also examined.
Interventions
DRUGregorafenib
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
An eligible subject must fulfill all of the following inclusion criteria: * Signed informed consent (IC) obtained before any study specific procedure. Patients must be able to understand and willing to sign the written IC. * Pathologically confirmed gastrointestinal stromal tumours. * All patients had received imatinib or sunitinib. * Pathological confirmed c-kit exon 17 mutation. * At least one measurable lesion in a non-irradiated area or allowed to be tracked whether there are circumstances recurrence by computed tomography (CT) or magnetic resonance imaging (MRI). * Aged \> 20 years old. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Life expectancy greater than 12 weeks. * Adequate bone marrow function: 1) Absolutely neutrophil count \>= 1.5 x10\^9/L or white blood cell count (WBC) \>= 4x10\^9/L; 2) Hemoglobin \>= 9 g/dL; 3) Platelet count \>= 100x10\^9/L. * Adequate liver function: 1) Total bilirubin \<= 1.5x the upper limit of normal (ULN); 2) Alanine Aminotransferase (ALT) & Aspartate Aminotransferase (AST) \<= 2.5x ULN if without liver metastasis or \<= 5x ULN if with hepatic metastasis; 3) Alkaline phosphatase \<= 2.5x ULN if without liver metastasis or \<= 5x ULN if with hepatic metastasis or bone metastasis; 4) Bilirubin \< 2x ULN. * Adequate renal function: creatinine \<1.5x ULN. * Patients must be accessible for treatment and follow-up in the participating centers.
Exclusion criteria
Subject will not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall clinical benefit rate | till 2 weeks after last dose | complete response (CR), partial response (PR), and stable disease (SD) |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | till study end, estimated 3 years |
| Overall survival (OS) | till study end, estimated 3 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in clinical biochemistry laboratory result by alanine aminotransferase(ALT) levels | till 2 weeks after last dose | (unit: U/L) |
| Adverse events (AEs) | till 2 weeks after last dose | Incidence of AEs will be shown and severity will be graded using NCI-CTCAE version 4.0 |
| Changes in clinical hematology laboratory result by hemoglobin (Hb) | till 2 weeks after last dose | (unit: g/dL) |
| Changes in clinical hematology laboratory result by hematocrit (Hct) | till 2 weeks after last dose | (unit: %) |
| Changes in clinical hematology laboratory result by platelet count | till 2 weeks after last dose | (unit: 10\^9/L) |
| Changes in clinical hematology laboratory result by red blood cell (RBC) count | till 2 weeks after last dose | (unit: 10\^9/L) |
| Changes in clinical hematology laboratory result by white blood cell (WBC) count | till 2 weeks after last dose | (unit: 10\^9/L) |
| Clinical hematology laboratory result by WBC differential | till 2 weeks after last dose | (unit: %) |
| Changes in clinical biochemistry laboratory result by potassium level | till 2 weeks after last dose | (unit: mmol/L) |
| Changes in clinical biochemistry laboratory result by calcium level | till 2 weeks after last dose | (unit: mmol/L) |
| Changes in clinical biochemistry laboratory result by glucose level | till 2 weeks after last dose | (unit: mmol/L) |
| Changes in clinical biochemistry laboratory result by lactate dehydrogenase (LDH) level | till 2 weeks after last dose | (unit: U/L) |
| Changes in clinical biochemistry laboratory result by blood urea nitrogen (BUN) level | till 2 weeks after last dose | (unit: mmol/L) |
| Changes in clinical biochemistry laboratory result by aspartate aminotransferase (AST) levels | till 2 weeks after last dose | (unit: U/L) |
| Changes in clinical biochemistry laboratory result by alkaline phosphatase (ALP) level | till 2 weeks after last dose | (unit: U/L) |
| Changes in clinical biochemistry laboratory result by thyroid-stimulating hormone (TSH) level | till 2 weeks after last dose | (unit: mIU/L) |
| Changes in clinical biochemistry laboratory result by creatinine level | till 2 weeks after last dose | (unit: mg/dL) |
| Changes in clinical biochemistry laboratory result by T4 level | till 2 weeks after last dose | (unit: mIU/L) |
| Changes in clinical urinalysis result by WBC count | till 2 weeks after last dose | (unit: 10\^9/L) |
| Changes in clinical urinalysis result by RBC count | till 2 weeks after last dose | (unit: 10\^9/L) |
| Changes in clinical urinalysis result by pH level | till 2 weeks after last dose | — |
| Changes in clinical urinalysis result by protein level | till 2 weeks after last dose | — |
| Changes in clinical urinalysis result by glucose level | till 2 weeks after last dose | (unit: mmol/L) |
| Changes in clinical coagulation results by prothrombin time (PT) | till 2 weeks after last dose | (unit: sec) |
| Changes in clinical coagulation results by activated partial thromboplastin time (APTT) | till 2 weeks after last dose | (unit: sec) |
| Changes in clinical coagulation results by international normalized ratio (INR) | till 2 weeks after last dose | — |
| Physical examination | till 2 weeks after last dose | — |
| Changes in vital signs by respiratory rate | till 2 weeks after last dose | (unit: times/min) |
| Changes in vital signs by pulse rate | till 2 weeks after last dose | (unit: times/min) |
| Changes in vital signs by systolic blood pressure | till 2 weeks after last dose | (unit: mmHg) |
| Changes in vital signs by diastolic blood pressure | till 2 weeks after last dose | (unit: mmHg) |
| Changes in vital signs by body temperature | till 2 weeks after last dose | (unit: degree celsius) |
| Changes in clinical biochemistry laboratory result by T3 level | till 2 weeks after last dose | (unit: mIU/L) |
| Changes in clinical biochemistry laboratory result by total and direct bilirubin levels | till 2 weeks after last dose | (unit: mg/dL) |
| Changes in clinical biochemistry laboratory result by albumin levels | till 2 weeks after last dose | (unit: g/L) |
Countries
Taiwan
Outcome results
None listed