Table 3.

Grade ≥ 3 hematologic and nonhematologic toxicities observed in the first course of therapy according to dose level

Number of patients with maximum toxicity grade observed
Dose levelToxicity345
1 (n = 5)Lymphopenia130
Leukopenia300
Neutropenia210
Thrombocytopenia020
Infection with normal ANC or grade 1 or 2 neutrophils200
2 (n = 4)Lymphopenia220
Thrombocytopenia120
Leukopenia210
Neutropenia210
Anemia100
3 (n = 3)Lymphopenia030
Leukopenia210
Neutropenia210
Thrombocytopenia210
Anemia010
Infection with normal ANC or grade 1 or 2 neutrophils100
Pain (Abdomen NOS)100
4 (n = 7)Neutropenia150
Thrombocytopenia150
Lymphopenia230
Leukopenia320
Anemia400
Hypokalemia11*0
ALT elevation100
AST elevation100
Infection with normal ANC or grade 1 or 2 neutrophils100
Amylase elevation100
5 (n = 2)Leukopenia020
Lymphopenia020
Neutropenia020
Thrombocytopenia02 a 0
Anemia100
Prolonged QTc interval1*00
Dehydration100
Nausea100
Vomiting100
Hemorrhage, CNS001 a
Hemorrhage, GI (oral cavity)1 a 00
AST elevation100
Infection with grade 3 or 4 neutrophils200
Amylase elevation100
Hyperglycemia100
Hypokalemia100
Pain (head/headache)100
5a (n = 6)Neutropenia330
Lymphopenia050
Thrombocytopenia140
Leukopenia320
Anemia200
Diarrhea100

NOTE: Toxicities attributed as unrelated to protocol therapy are not shown.