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. Author manuscript; available in PMC: 2014 May 1.
Published in final edited form as: Curr Probl Cancer. 2013 May-Jun;37(3):110–144. doi: 10.1016/j.currproblcancer.2013.06.001

Table 8.

General eligibility criteria used for early phase trials in drug development are listed. ECG QTc was not required for every drug development trial.

Eligibility Criteria Value
Absolute Neutrophil Count ≥1,500/μL
Platelet Count ≥100,000/μL
Total Bilirubin ≤1.5 × institutional ULN
AST/ALT ≤2.5 × ULN, if liver metastasis, ≤5 × ULN (Patients who have both bilirubin >ULN and AST/ALT >ULN were not generally eligible in early phase drug trials)
Creatinine or Creatinine ≤1.5 × ULN
Clearance ≥60 mL/minute/1.73m2 if creatinin≥ 1.5 × ULN
Urinalysis Protein ≤1+, If ≥2+, 24-hr protein should be < 1 g (or protein/creatinine ratio <1);usually needed for antiangiogenetic KIs
ECG QTc ≤ 450 ms for males, ≤ 470 ms for females

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; KI, kinase inhibitor; LLN, lower limit of normal; ULN, upper limit of normal.