Table 3.
Dose-level 1 (n = 3) | Dose-level 2 (n = 25) | Dose-level 3 (n = 8) | Total (N = 36) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
GSK3052230 | 10 mg/kg | 15 mg/kg | 20 mg/kg | ||||||||||
Adverse Event, (n %) | Grade 1/2 | Grade 3 | Grade 1/2 | Grade 3 | Grade 1/2 | Grade 3 | |||||||
Nausea | 2 | (67%) | 11 | (44%) | 1 | (4%) | 6 | (75%) | 20 (56%) | ||||
Decreased appetite | 3 | (100%) | 7 | (28%) | 3 | (38%) | 13 (36%) | ||||||
Infusion related reaction | 1 | (33%) | 6 | (24%) | 1 | (4%) | 3 | (38%) | 2 | (25%) | 13 (36%) | ||
Neutrophil count decreased | 1 | (33%) | 1 | (33%) | 3 | (12%) | 6 | (24%) | 2 | (26%) | 13 (36%) | ||
Fatigue | 1 | (33%) | 7 | (28%) | 4 | (50%) | 12 (33%) | ||||||
Asthenia | 0 | 5 | (20%) | 1 | (4%) | 3 | (38%) | 9 (25%) | |||||
Blood creatinine increased | 1 | (33%) | 6 | (24%) | 2 | (25%) | 9 (25%) | ||||||
Vomiting | 1 | (33%) | 4 | (16%) | 1 | (4%) | 3 | (38%) | 9 (25%) | ||||
Anemia | 1 | (33%) | 4 | (16%) | 2 | (8%) | 0 | 7 (19%) | |||||
Peripheral sensory neuropathy | 1 | (33%) | 6 | (24%) | 0 | 7 (19%) | |||||||
Dysgeusia | 1 | (33%) | 3 | (12%) | 2 | (25%) | 6 (17%) | ||||||
Hypertension | 0 | 4 | (16%) | 1 | (13%) | 1 | (13%) | 6 (17%) | |||||
Lacrimation increased | 2 | (67%) | 4 | (16%) | 0 | 6 (17%) | |||||||
Diarrhea | 1 | (33%) | 1 | (4%) | 1 | (4%) | 1 | (13%) | 4 (11%) | ||||
Hiccups | 0 | 3 | (12%) | 1 | (13%) | 4 (11%) | |||||||
Leukopenia | 0 | 4 | (16%) | 0 | 4 (11%) | ||||||||
Tinnitus | 1 | (33%) | 2 | (8%) | 1 | (13%) | 4 (11%) | ||||||
Abdominal pain upper | 0 | 3 | (12%) | 1 | (4%) | 0 | 3 (8%) | ||||||
ALT increased | 3 | (12%) | 3 (8%) | ||||||||||
Alopecia | 0 | 3 | (12%) | 0 | 3 (8%) | ||||||||
AST increased | 0 | 3 | (12%) | 0 | 3 (8%) | ||||||||
Constipation | 0 | 2 | (8%) | 1 | (13%) | 3 (8%) | |||||||
Hypoesthesia | 0 | 2 | (8%) | 1 | (13%) | 3 (8%) | |||||||
Mucosal inflammation | 0 | 2 | (8%) | 1 | (13%) | 3 (8%) | |||||||
Paresthesia | 0 | 3 | (12%) | 0 | 3 (8%) | ||||||||
Rash | 1 | (33%) | 2 | (8%) | 1 | (13%) | 3 (8%) | ||||||
Weight decreased | 0 | 2 | (8%) | 1 | (13%) | 3 (8%) |
Abbreviations: ALT Alanine aminotransferase, AST Aspartate aminotransferase