Table 2.
IPI-926 dose level | 130 mg | 160 mg | Total | ||||||
---|---|---|---|---|---|---|---|---|---|
Evaluable patients | 3 | 6 | 9 | ||||||
Patients with a DLT | 0 | 0 | 0 | ||||||
Grade | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
Attributed to IPI-926 | |||||||||
Nausea | 2 | 0 | 0 | 1 | 0 | 0 | 3 | 0 | 0 |
Muscle Cramps | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
Fatigue | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 0 |
Alopecia | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Dysguesia | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
Elevated AST | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
Attributed to Cetuximab | |||||||||
Acneiform rash | 2 | 0 | 0 | 2 | 0 | 0 | 4 | 0 | 0 |
Dry skin/desquamation | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 |
Infusion reaction | 0 | 0 | 0 | 0 | 0 | 1* | 0 | 0 | 1 |
Diarrhea | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
Mucositis | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
Hypomagnesemia | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
The patient with a grade 3 infusion reaction to cetuximab was removed from study following his loading dose of cetuximab and never received IPI-926.