. 2014 May 8;6:87–96. doi: 10.2147/CPAA.S62512

Table 1.

Overview of Phase II safety study designs11–16

	PX-171-003-A0 NCT00511238 17	PX-171-003-A1 NCT00511238 17	PX-171-004 NCT00530816 18	PX-171-005 NCT00721734 19
Key eligibility criteria
Prior therapy	▪ Relapsed and refractory	▪ Relapsed and refractory	▪ Relapsed and/or refractory	▪ Relapsed,refractory, and/or progressive
	▪ ≥2 prior regimens	▪ ≥2 prior regimens	▪ 1–3 prior regimens	▪ ≥2 prior regimens
	▪ Responded to ≥1 regimen	▪ Responded to ≥1 regimen	▪ Responded to 1st-line regimen	▪ Responded to ≥1 regimen
	▪ Refractory to most recent	▪ Refractory to most recent
	▪ Prior tx with bortezomib, IMiD, anthracycline, and alkylating agents	▪ Prior tx with bortezomib, IMiD, anthracycline, and alkylating agents
Other	▪ ECOG PS 0–2	▪ ECOG PS 0–2	▪ ECOG PS 0–2	▪ ECOG PS 0–2
	▪ No significant CVD^a	▪ No significant CVD^a	▪ No significant CVD^a	▪ No significant CVD^a
	▪ No grade 3/4 PN or grade 2 with pain	▪ No grade 3/4 PN or grade 2 with pain	▪ No grade 3/4 PN or grade 2 with pain	▪ No grade 3/4 PN or grade 2 with pain
Lab values
Platelets	≥50,000/mm³	≥50,000/mm³	≥50,000/mm³	≥30,000/mm³
Hb	≥8 g/dL	≥8 g/dL	≥8 g/dL	≥7 g/dL
ANC	≥1,000/mm³	≥1,000/mm³	≥1,000/mm³	≥1,000/mm³
AST/ALT	<3× ULN	<3× ULN	Adequate hepatic function	Adequate hepatic function
CrCl	>30 mL/min	>30 mL/min	>30 mL/min	Various levels of RI
Treatment
Carfilzomib dose^b	20 mg/m²	20/27 mg/m²^c	20 or 20/27 mg/m²^c	15/20/27 mg/m²^d
Max planned cycles	12 cycles	12 cycles	12 cycles	12 cycles

Notes:

New York Heart Association Class III–IV heart failure or recent myocardial infarction/unstable angina were excluded

administered as a 2–10 min intravenous infusion on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle

starting dose of 20 mg/m² in cycle 1, target dose of 27 mg/m² thereafter

starting dose 15 mg/m² for cycle 1, 20 mg/m² for cycle 2 with target dose of 27 mg/m² thereafter.

Abbreviations: ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; CrCl, creatinine clearance; CVD, cardiovascular disease; ECOG, Eastern Cooperative Oncology Group; Hb, hemoglobin; IMID, immunomodulatory drug; min, minute; PN, peripheral neuropathy; PS, performance status; RI, renal insufficiency; ULN, upper limit of normal.