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. Author manuscript; available in PMC: 2022 Oct 1.
Published in final edited form as: Clin Cancer Res. 2022 Apr 1;28(7):1313–1322. doi: 10.1158/1078-0432.CCR-21-3729

Table 1. Dose escalation schema.

The ‘outer layer’ of this nested dose escalation trial escalated the dose of the two drugs by sequentially going through dose levels 1–7 in the table using the standard algorithm of the 3+3 design. If the provisional MTD for decitabine in combination with 0.25 mg talazoparib had been dose level 1 or 2, one or the other of the ‘inner layers’ of the trial (a, b, c) would have been activated, escalating the dose of talazoparib with the dose of decitabine remaining fixed.

Talazoparib po x 28 days
0.25 mg 0.50 mg 0.75 mg 1.0 mg
Decitabine IV X 5 days 10 mg/m 2 1 1a 1b 1c
15 mg/m 2 2 2a 2b 2c
20 mg/m 2 3 4 5 6
Decitabine IV X 10 days 20 mg/m 2 7

IV – intravenously

po – orally