Table 1.

Dose escalation table

Dose level	BKM120 (mg daily)	100 % mFOLFOX6 (D1, D15)	Total patients	Number of evaluable patients for DLT	Number of patients with DLT
1	40	Oxaliplatin: 85 mg/m2	4	3	0
		Leucovorin: 400 mg/m2
		5-FU bolus: 400 mg/m2
		5-FU infusion: 2400 mg/m2
2	60	Oxaliplatin: 85 mg/m2	10	8	4
		Leucovorin: 400 mg/m2			Hyperglycemia (grade 3)
		5-FU bolus: 400 mg/m2			AST/ALT elevation (grade 3)
		5-FU infusion: 2400 mg/m2			neutropenia (grade 4)
					febrile neutropenia (grade 4)
					thrombocytopenia (grade 4)
3	80	Oxaliplatin: 85 mg/m2	3	2	1
		Leucovorin: 400 mg/m2			neutropenia (grade 4)
		5-FU bolus: 400 mg/m2
		5-FU infusion: 2400 mg/m2