Table 1.

Demographics and baseline characteristics

600 mg + DT600 mg750 mg900 mgTotal
Categoryn = 3n = 8n = 9n = 1N = 21a
Age (y)b74 (72–77)68 (44–83)68 (57–79)81 (81–81)68 (44–83)
Racec
 White3 (100)7 (88)7 (78)1 (100)18 (86)
 Black0 (0)0 (0)2 (22)0 (0)2 (10)
 Other0 (0)1 (12)d0 (0)0 (0)1 (5)
BMI (kg/m2)b28.1 (23.6–29.1)30.5 (26.3–42.9)29.7 (25.8–42.5)25.2 (25.2–25.2)29.1 (23.6–42.9)
Disease status
 PSA (ng/mL)b18.5 (2.1–140.5)27.8 (5.4–186.8)22.4 (3.5–145.5)20.322.5 (2.1–186.8)
 Bone diseasec,e2 (67)5 (63)7 (78)1 (100)15 (71)
 Lymph nodec,e2 (67)5 (63)5 (56)0 (0)12 (57)
 Visceral diseasec,e1 (33)4 (50)1 (11)0 (0)6 (29)
Prior treatments
 AA- and ENZA-Naïvec3 (100)4 (50)2 (22)0 (0)9 (43)
 Prior ENZAc0 (0)2 (25)1 (11)1 (100)4 (19)
 Prior AAc0 (0)2 (25)4 (44)0 (0)6 (29)
 Prior ENZA + AAc0 (0)0 (0)2 (22)a0 (0)2 (10)
  • Abbreviations: AA, abiraterone acetate; DT, dose titration; ENZA, enzalutamide.

  • aOne subject discontinued before Cycle 1 Day 14 and is only included in the safety population.

  • bMedian (range).

  • cn (%).

  • dNot reported.

  • eSubjects may be counted more than once.