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Table 4 Differences in mean percent BrdU uptake in ex vivo lymphocyte assays in subjects treated at RP2D of dinaciclib 12 mg/m 2

From: A first-in-human, phase 1, dose-escalation study of dinaciclib, a novel cyclin-dependent kinase inhibitor, administered weekly in subjects with advanced malignancies

Time points Number of patients Mean percent difference in BrdU uptake (95% CI) Standard error Degrees of freedom t P value
Day 1 Predose – 2 hours 7 10.72 (4.69, 16.75) 2.46 6 4.35 0.005
Predose – 3 hours 7 9.28 (1.44, 17.13) 3.21 6 2.89 0.028
Predose – 4 hours 7 6.05 (-4.03, 16.12) 4.12 6 1.47 0.192
Predose – 6 hours 7 10.16 (3.89, 16.43) 2.56 6 3.96 0.007
Predose – 8 hours 6 8.76 (2.87, 14.65) 2.29 5 3.82 0.012
Day 15 Predose – 2 hours 7 14.82 (6.02, 23.61) 3.59 6 4.12 0.006
Predose – 3 hours 7 12.95 (2.01, 23.89) 4.47 6 2.90 0.028
Predose – 4 hours 7 5.47 (-4.17, 15.12) 3.94 6 1.39 0.214
Predose – 6 hours 6 15.90 (7.69, 24.11) 3.19 5 4.98 0.004
Predose – 8 hours 5 16.48 (5.63, 27.34) 3.91 4 4.21 0.014
  1. BrdU = bromodeoxyuridine; PHA = phytohemagglutinin; RP2D = recommended phase 2 dose.
  2. Results of paired t-tests showing the difference in mean percent BrdU uptake between predose and postdose ex vivo PHA lymphocyte stimulation assays.