Table 1.

Baseline demographics and patient characteristics

Demographic/characteristicArm 1 (N = 51)Arm 2 (N = 20)Food effects (N = 13)Total (N = 84)
Sex, n (%)
 Male27 (52.9)8 (40.0)7 (53.8)42 (50.0)
 Female24 (47.1)12 (60.0)6 (46.2)42 (50.0)
Age, y
 Mean61.760.460.161.1
 Median61.061.062.061.0
 Range41–8329–7643–7429–83
Race/ethnicity, n (%)
 White42 (82.4)16 (80.0)12 (92.3)70 (83.3)
 Hispanic/Latino2 (3.9)0 (0.0)1 (7.7)3 (3.6)
 African-American5 (9.8)2 (10.0)07 (8.3)
 Asian2 (3.9)2 (10.0)04 (4.8)
ECOG PSa
 015 (30.0)8 (40.0)3 (23.0)26 (31.3)
 135 (70.0)12 (60.2)10 (77.0)57 (68.7)
Number of prior anticancer systemic treatments for metastatic disease, n (%)
 03 (5.9)1 (5.0)0 (0.0)4 (4.8)
 15 (2.0)2 (10.0)1 (7.7)8 (9.5)
 210 (19.6)4 (20.0)3 (23.1)17 (20.2)
 33 (5.9)4 (20.0)4 (30.8)11 (13.1)
 >330 (58.8)9 (45.0)5 (38.4)44 (52.4)
Tumor type, n (%)
 CRC9 (17.6)7 (35.0)4 (31.8)20 (23.8)
 Ovarian6 (11.8)5 (25.0)1 (7.7)12 (12.3)
 Head and neck8 (15.7)1 (5.0)0 (0.0)9 (10.7)
 NSCLC4 (7.8)0 (0.0)2 (15.3)6 (7.1)
 Melanoma3 (5.9)1 (5.0)2 (15.3)6 (7.1)
 Breast3 (5.9)0 (0.0)0 (0.0)3 (3.6)
 Otherb16 (31.3)4 (20.0)4 (30.8)24 (28.6)

Abbreviations: Arm 1, intermittent dosing; Arm 2, continuous dosing.

  • aECOG PS was not available for 1 patient in arm 1.

  • bOther includes: 2 each of leiomyosarcoma, skin (squamous cell), prostate, small-cell lung, kidney, and anaplastic thyroid cancer; and 1 each of adenocystic, hepatoma, gastrointestinal stromal, chondrosarcoma, endometrial, salivary gland, pancreatic islet cell, pancreatic neuroendocrine, pancreatic, esophageal, sarcoma, cholangiocarcinoma, urothelial, and gastric cancers.