Table 1.

Overview of Clinical Trials Included in Population PK Analysis

Study	Description	Dose Regimen	Patient Population	No. of Patientsa	PK Samples	ClinicalTrials.gov No.
111	Phase 1 dose‐ranging study	0.1 to 3.6 mg/kg intravenously every 3 weeks (2‐hour infusion)	Relapsed/refractory CD30‐expressing hematologic malignancies	48b	Rich	NCT00430846
212	Phase 1 dose‐ranging study	0.4 to 1.4 mg/kg intravenously on days 1, 8, and 15 of every 28‐day cycle (2‐hour or 30‐minute infusion)c	Relapsed/refractory CD30‐expressing hematologic malignancies	46b	Rich	NCT00649584
32	Phase 2 pivotal study in HL	1.8 mg/kg intravenously every 3 weeks (30‐minute infusion)	Relapsed/refractory HL; previous autologous stem cell transplant	102	Sparse	NCT00848926
41	Phase 2 pivotal study in sALCL	1.8 mg/kg intravenously every 3 weeks (30‐minute infusion)	Relapsed/refractory sALCL; previous frontline chemotherapy	58	Sparse	NCT00866047
518, 25	Phase 1 clinical pharmacology study	1.2 or 1.8 mg/kg intravenously every 3 weeks (30‐minute infusion)	Relapsed/refractory CD30‐expressing hematologic malignancies	60d	Rich	NCT01026415

HL, Hodgkin lymphoma; sALCL, systemic anaplastic large cell lymphoma.

^aNumber of patients contributing to population PK analyses.

^bIncludes 5 patients who were reenrolled with new patient numbers and retreated in study 1 (n = 3) or in study 2 (n = 2).

^cProtocol amended to reduce infusion time.

^dIncludes 56 patients from the drug–drug interaction portion of the study and 4 patients with renal impairment.