Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT01440959
Eligibility Criteria:
Inclusion criteria
* Age 20 years or older
* Histologically confirmed metastatic and/or advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
* Failed (progressed and/or intolerable) after prior treatments for GIST, including at least both imatinib and sunitinib .
* ECOG performance status of 0\~2
* Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 3.0
* At least one measurable lesion as defined by RECIST version 1.0.
* Adequate bone marrow, hepatic, renal, and other organ functions
* Neutrophil \> 1,500/mm3
* Platelet \> 75,000/mm3
* Hemoglobin \> 8.0 g/dL
* Total bilirubin \< 1.5 x upper limit of normal (ULN)
* AST/ALT \< 2.5 x ULN (or \< 5 x ULM in case of liver metastases)
* Creatinine \< 1.5 x ULN
* Amylase, lipase \< ULN
* Electrolytes should be within normal limits.
* Urine dipstick reading: Negative for proteinuria or, if documentation of +1 results for protein on dipstick reading, then total urinary protein ≤ 500 mg and measured creatinine clearance ≥ 50 mL/min/1.73m2 from a 24-hour urine collection
* Life expectancy \> 12 weeks
* Women with reproductive potential must have a negative serum or urine pregnancy test
* Washout period of previous TKIs or chemotherapy for more than 4 times the half life.
* Provision of a signed written informed consent
Exclusion criteria
* Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
* Clinically significant cardiac disease (New York Heart Association, Class III or IV) or impaired cardiac function or clinically significant cardiac diseases,
* Uncontrolled infection.
* Diabetes mellitus (insulin dependent or independent disease, requiring chronic medication) with signs of clinically significant peripheral vascular disease.
* Previous pericarditis; clinically significant pleural effusion in the previous months or current ascites requiring two or more interventions/month.
* Known pre-existing clinically significant disorder of the hypothalamic-pituitary axis, adrenal or thyroid glands.
* Prior acute or chronic pancreatitis of any etiology.
* Acute and chronic liver disease and all chronic liver impairment.
* Malabsorption syndrome or uncontrolled gastrointestinal toxicities with toxicity greater than NCI CTCAE grade 2.
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality.
* Treatment with any of the medications that have a potential risk of prolonging the QT interval or inducing Torsades de Points and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
* Use of ketoconazole, erythromycin, carbamazepine, phenobarbital, rifampin, phenytoin and quinidine 2 weeks prior baseline.
* Major surgery ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy.
* Known diagnosis of HIV infection .
* History of another primary malignancy that is currently clinically significant or currently requires active intervention.
* Patients with brain metastases as assessed by radiologic imaging
* Alcohol or substance abuse disorder.
* no other inhibitor of FGFR except sunitinib
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01440959
Study Brief:
Protocol Section:
NCT01440959