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. 2016 Jul 15;10:2289–2297. doi: 10.2147/DDDT.S93941

Table 2.

Main characteristics and outcomes of the ARMOR1 and ARMOR2 clinical trials

ARMOR169 ARMOR2, part 169 ARMOR2, parts 1 and 2 (combined study)70
Number of patients 49 28 107
Metastatic disease (M) 51% 86% 77%
Abi-R or Enz-R patients No Abi-R: three patients Abi-R: 37 patients
Enz-R: nine patients
Drug formulation Capsules SDD tablets SDD tablets
Food effect Yes No No
Dose range 650 mg 1,700 mg 2,550 mg
975 mg 2,550 mg
1,300 mg 3,400 mg
1,950 mg
2,600 mg
PSA decline ≥30% 49% 64% 83%a
PSA50 22.4% 48% 70%a

Note:

a

PSA decline results in the M0 and M1 treatment-naïve cohorts.

Abbreviations: Abi-R, abiraterone refractory; Enz-R, enzalutamide refractory; SDD, spray dry dispersion; PSA50, PSA decline ≥50%.