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

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

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

BrdU = bromodeoxyuridine; PHA = phytohemagglutinin; RP2D = recommended phase 2 dose.
Results of paired t-tests showing the difference in mean percent BrdU uptake between predose and postdose ex vivo PHA lymphocyte stimulation assays.

ISSN: 1479-5876