Table 2.

Exclusion criteria.

1. Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, etc., confirmed by ophthalmologic examination. 2. Any active malignancies except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix. 3. Poorly controlled arterial hypertension (systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg) despite standard medical management. 4. Serious cardiovascular disease: II level myocardial ischemia or myocardial infarction, arrhythmia (including QT interval prolongation, for man >450 ms, for woman >470 ms); III–IV level cardiac function insufficiency, or echocardiography showed that left ventricular ejection fraction (LVEF) <50%. 5. Positive urinary protein (urine protein detection of 2 or more, or 24-hour urine protein > 1.0 g). 6. Total bilirubin ⩾1.5 × upper limit of normal (ULN; ⩾2.5 × ULN if Gilbert syndrome or metastatic disease involving liver). 7. AST and ALT >2.5 × ULN (AST and ALT >5 × ULN in the presence of liver metastases). 8. Creatinine clearance ⩽30 ml/min based on Cockcroft–Gault. 9. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction). 10. Serum phosphate > institutional ULN. 11. Serum calcium outside of the institutional normal range or serum albumin-corrected calcium outside of the institutional normal range when serum albumin is outside of the institutional normal range. 12. History of calcium/phosphate homeostasis disorder. 13. History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification. 14. Current evidence of significant corneal disorder/keratopathy or retinal disorder, confirmed by ophthalmologic examination. 15. Factors of high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months; unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by Pis based on gastric endoscopy result. 16. Abnormal Coagulation (INR > 1.5 APTT > 1.5 UNL), with tendency of bleed. 17. Known hypersensitivity or severe reaction to INCB054828 or excipients of INCB054828 study drug 18. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.