. Author manuscript; available in PMC: 2023 Jan 1.

Published in final edited form as: Cancer Chemother Pharmacol. 2021 Oct 20;89(1):49–58. doi: 10.1007/s00280-021-04350-x

TABLE 2.

Treatment Cohorts and Dose Levels

Treatment Arm	Dose Level	Veliparib every 12 hours		Cyclophosphamide IV over 60 minutes		Doxorubicin IVP over 15 minutes		No. Patients (n)	No. of Pts with DLTS
Treatment Arm	Dose Level	mg	Days	mg/m²	Days	mg/m²	Days	No. Patients (n)	No. of Pts with DLTS
Group 1	Level 1	10	Days 1-4	450	Day 3	-		3	0
	Level 2	20		450		-		3	0
	Level 3	50		450		-		6	1
	Level 4	50		600		-		3	0
	Level 5	50		750		-		3	0
	Level 6	100		750		-		7	2 (near DLTs^*)
	Level 7	150		750		-		3	0
	Level 8	200		750		-		3	0
Group 2	Level la	50	Days 1-4	600	Day 3	60	Day 3	3	0
	Level 2a	100		600		60		13	0
	Level 3a	150		600		60		6	2
Group 3	Level 1b	100	Days 1-7	600	Day 1	60	Day 1	14	0
Group 4	Level 1b	100	Days 1-14	600	Day 1	60	Day 1	13	0

Near DLTs were a grade 3 and a grade 4 neutropenia requiring dose reduction of cyclophosphamide.

Abbreviation: DLTs, dose-limiting toxicities.