Table 1.

Patients’ demography and characteristics

	Arm 1	Arm 2	Arm 3
Enrolled (n = 69)	23 (33.3%)	22 (31.9%)	24 (34.8%)
Safety evaluable (n = 67)	22 (32.8%)	22 (32.8%)	23 (34.4%)
Efficacy evaluable (n = 60)	17 (28.3%)	21 (35.0%)	22 (36.7%)
Sexa
Female	9 (40.9%)	14 (63.6%)	10 (43.5%)
Male	13 (59.1%)	8 (36.4%)	13 (56.5%)
Patient with baseline LDH,U/la
0 < LDH < 250	17 (77.3%)	20 (90.9%)	20 (87.0%)
LDH > 250	5 (22.7%)	2 (9.1%)	3 (13.0%)
ECOGa
0	19 (86.4%)	17 (77.3%)	20 (87.0%)
1	3 (13.6%)	5 (22.7%)	3 (13.0%)
Stage of metastatic disease at baselinea
IV M1a	5 (22.7%)	5 (22.7%)	6 (26.1%)
IV M1b	9 (40.9%)	11 (50.0%)	5 (21.7%)
IV M1c	8 (36.4%)	6 (27.3%)	12 (52.2%)
Prior systemic antineoplastica
Chemotherapy	9 (40.9%)	11 (50.0%)	11 (47.8%)
Radiotherapy	4 (18.2%)	2 (9.1%)	4 (17.4%)

^aPercent based on safety evaluable population