Treatment Modifications Detail View

PCI-24781 Dose Levels: 0 = 30 mg/m2 1 = 60 mg/m2 2 = 90 mg/m2 3 = 120 mg/m2			Doxorubicin Dose Levels: 1 = 75 mg/m2 2 = 60mg/m2 3 = 45 mg/m2
PCI-24781 Treatment			Doxorubicin Treatment
Dose Level	Dose Modifications	Number of cycles	Dose Level	Dose Modifications	Number of cycles
0	No modifications	2	1	No modifications	3
0	No modifications	5	1	No modifications	5
0	No modifications	10	1	No modifications	6
1	No modifications	1	1	No modifications	1
1	1 dose withheld	1	1	No modifications	1
1	No modifications	2	1	No modifications	2
1	1 dose modifcation to dose level 0, 10 doses withheld	6	1	No modifications	4
1	3 doses withheld	10	1	No modifications	6
1	No modifications	1	1	No modifications	1
1	1 dose modification to dose level 0	6	1	1 dose modification to dose level 2	6
2	No modifications	6	1	No modifications	6
2	1 dose modification	3	1	1 dose modification	3
2	1 dose missed	2	1	No modifications	2
2	No modifications	7	1	No modifications	6
2	1 dose withheld	2	1	No modifications	2
2	No modifications	2	1	No modifications	2
3	No modifications	1	1	No modifications	1
3	9 doses withheld and 1 dose modification to dose level 2	5	1	2 doses withheld and 1 dose modification in dose level 2	5
3	No modifications	4	1	No modifications	4
*
3	No modifications	2	1	No modifications	2
3	No modifications	1	1	No modifications	1

Summary:

Dose Level 0: No Modifications for 3 subjects

Dose Level 1: Modifications/holds for 4 out of 7 subjects

Dose Level 2: Modifications/holds for 3 out of 6 subjects

Dose Level 3: Modifications/holds for 1 out of 5 subjects

^*Patient’s data removed from analysis as patient withdrew consent 2 days after starting treatment.