Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients With CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01026415

Enrollment

Registered

2009-12-04

Start date

2009-12-31

Completion date

2012-05-31

Last updated

2014-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinomas, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Neoplasms

Keywords

Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, monomethyl auristatin E, Drug Therapy, Immunotherapy, Hematologic Diseases, Lymphoma, Antibodies, Monoclonal

Brief summary

The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion. The study will also assess blood drug levels in patients with renal or hepatic impairment (special populations).

Interventions

DRUGbrentuximab vedotin

1.8 mg/kg IV every 21 days

DRUGrifampin

600 mg/day PO

DRUGmidazolam

1 mg IV

DRUGketoconazole

400 mg/day PO

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adequate organ function (Special Populations: serum bilirubin \>2 mg/dL or creatinine clearance \<50 mL/min) * ECOG performance status \<2 (Special Populations: \<4) * Relapsed or refractory CD30-positive malignancy

Exclusion criteria

* Receiving prohibited medication within 4 weeks * Poor liver function (Child-Pugh class C) * Current diagnosis of primary cutaneous ALCL * Acute or chronic graft-versus-host disease

Design outcomes

Primary

Measure	Time frame
Midazolam blood concentrations +/- brentuximab vedotin	3 weeks
Brentuximab vedotin blood concentrations +/- rifampin	6 weeks
Brentuximab vedotin in urine, feces, and blood	1 week
Brentuximab vedotin blood concentrations in special populations	3 weeks
Brentuximab vedotin blood concentrations +/- ketoconazole	6 weeks

Secondary

Measure	Time frame
Incidence of adverse events and laboratory abnormalities	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026