Gastrointestinal Stromal Tumour (GIST) Clinical Trial
Official title:
A Phase 2 Study of Regorafenib in Metastatic Gastrointestinal Stromal Tumours With C-KIT exon17 Mutation
| NCT number | NCT02606097 |
| Other study ID # | 17298 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | April 2014 |
| Est. completion date | May 2018 |
| Verified date | March 2019 |
| Source | Chang Gung Memorial Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | May 2018 |
| Est. primary completion date | May 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
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 exclusion criteria: - Major surgery within four weeks prior to entering the study. - Patients with central nervous system (CNS) metastasis, including clinical suspicion. - Patients who are under active or uncontrolled infections. - Patients who with unstable angina (angina symptoms at rest, new-onset angina (begun within the last 3 months) or myocardial infarction history 6 months before entry. - Cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). - Congestive heart failure New York Heart Association (NYHA) class 2. - Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management. - Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication. - Patients who are pregnant or with breast feeding. - Other concomitant or previously malignancy within 5 years except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only. - Mental status is not fit for clinical trial. - Cannot take study medication orally. - Fertile men and women unless using a reliable and appropriate contraceptive method. - Patients with evidence or history of any bleeding diathesis, irrespective of severity. - Any hemorrhage or bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks prior to the start of study medication. - Non-healing wound, ulcer, or bone fracture. - Renal failure requiring hemo-or peritoneal dialysis. |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Chang Gung Memorial Hospital | Taoyuan |
| Lead Sponsor | Collaborator |
|---|---|
| Chang Gung Memorial Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Adverse events (AEs) | Incidence of AEs will be shown and severity will be graded using NCI-CTCAE version 4.0 | till 2 weeks after last dose | |
| Other | Changes in clinical hematology laboratory result by hemoglobin (Hb) | (unit: g/dL) | till 2 weeks after last dose | |
| Other | Changes in clinical hematology laboratory result by hematocrit (Hct) | (unit: %) | till 2 weeks after last dose | |
| Other | Changes in clinical hematology laboratory result by platelet count | (unit: 10^9/L) | till 2 weeks after last dose | |
| Other | Changes in clinical hematology laboratory result by red blood cell (RBC) count | (unit: 10^9/L) | till 2 weeks after last dose | |
| Other | Changes in clinical hematology laboratory result by white blood cell (WBC) count | (unit: 10^9/L) | till 2 weeks after last dose | |
| Other | Clinical hematology laboratory result by WBC differential | (unit: %) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by potassium level | (unit: mmol/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by calcium level | (unit: mmol/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by glucose level | (unit: mmol/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by lactate dehydrogenase (LDH) level | (unit: U/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by blood urea nitrogen (BUN) level | (unit: mmol/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by creatinine level | (unit: mg/dL) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by total and direct bilirubin levels | (unit: mg/dL) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by albumin levels | (unit: g/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by alanine aminotransferase(ALT) levels | (unit: U/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by aspartate aminotransferase (AST) levels | (unit: U/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by alkaline phosphatase (ALP) level | (unit: U/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by thyroid-stimulating hormone (TSH) level | (unit: mIU/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by T3 level | (unit: mIU/L) | till 2 weeks after last dose | |
| Other | Changes in clinical biochemistry laboratory result by T4 level | (unit: mIU/L) | till 2 weeks after last dose | |
| Other | Changes in clinical urinalysis result by WBC count | (unit: 10^9/L) | till 2 weeks after last dose | |
| Other | Changes in clinical urinalysis result by RBC count | (unit: 10^9/L) | till 2 weeks after last dose | |
| Other | Changes in clinical urinalysis result by pH level | till 2 weeks after last dose | ||
| Other | Changes in clinical urinalysis result by protein level | till 2 weeks after last dose | ||
| Other | Changes in clinical urinalysis result by glucose level | (unit: mmol/L) | till 2 weeks after last dose | |
| Other | Changes in clinical coagulation results by prothrombin time (PT) | (unit: sec) | till 2 weeks after last dose | |
| Other | Changes in clinical coagulation results by activated partial thromboplastin time (APTT) | (unit: sec) | till 2 weeks after last dose | |
| Other | Changes in clinical coagulation results by international normalized ratio (INR) | till 2 weeks after last dose | ||
| Other | Physical examination | till 2 weeks after last dose | ||
| Other | Changes in vital signs by respiratory rate | (unit: times/min) | till 2 weeks after last dose | |
| Other | Changes in vital signs by pulse rate | (unit: times/min) | till 2 weeks after last dose | |
| Other | Changes in vital signs by systolic blood pressure | (unit: mmHg) | till 2 weeks after last dose | |
| Other | Changes in vital signs by diastolic blood pressure | (unit: mmHg) | till 2 weeks after last dose | |
| Other | Changes in vital signs by body temperature | (unit: degree celsius) | till 2 weeks after last dose | |
| Primary | Overall clinical benefit rate | complete response (CR), partial response (PR), and stable disease (SD) | till 2 weeks after last dose | |
| Secondary | Progression free survival (PFS) | till study end, estimated 3 years | ||
| Secondary | Overall survival (OS) | till study end, estimated 3 years |