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. Author manuscript; available in PMC: 2018 Dec 1.
Published in final edited form as: Cancer. 2017 Aug 17;123(23):4617–4630. doi: 10.1002/cncr.30892

Table 8.

Secondary efficacy endpoints

Phase 2 Filanesib
(N=32)
Phase 2 Filanesib/Dex
(N=55)
Time to response, months
  N 5 8
  Median (min, max) 4.4 (2.6, 15.9) 2.9 (0.8, 3.7)
  95% CI 2.6, 15.9 0.8, 3.5
Duration of response, months
  N 5 8
  Median (min, max) 8.6 (1.4, 36.9*) 4.4 (2.4, 21.4)
  95% CI 1.4, NR 2.4, 8.1
PFS, months
  N 32 55
  Median (min, max) 1.6 (0.0*, 39.4*) 2.8 (0.3, 24.6)
  95% CI 1.0, 3.3 1.0, 4.2
TFI, months
  N 32 55
  Median (min, max) 0.9 (0.0*, 16.1*) 1.0 (0.0, 2.8*)
  95% CI 0.8, 1.5 0.8, 1.4
TNT, months
  N 32 55
  Median (min, max) 4.1 (0.6, 39.9*) 6.1 (0.4*, 26.9*)
  95% CI 2.3, 12.0 3.8, 7.4
OS, months
  N 32 55
  Median (min, max) 19.0 (0.6*, 39.9*) 10.7 (0.4, 28.3*)
  95% CI 7.8, 23.3 5.6, 13.4

Time to response and duration of response were calculated using responders only. Other parameters were calculated using the safety population.

*

Patient ongoing.

Abbreviations: CI = confidence interval; Dex = dexamethasone; max = maximum; min = minimum; N or n = number; NR = not reached; OS = overall survival; PFS = progression-free survival; TFI = treatment-free interval; TNT = time to next treatment