Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

Seagen

Status and phase: Completed; Phase 1

Conditions: Lymphoma, Large-Cell, Anaplastic; Carcinomas; Neoplasms; Disease, Hodgkin; Lymphoma, Non-Hodgkin

Treatments: Drug: midazolam; Drug: brentuximab vedotin; Drug: ketoconazole; Drug: rifampin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01026415

SGN35-008

Details and patient eligibility

About

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).

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 4 patient groups

1

Experimental group

Description:

midazolam +/- brentuximab vedotin

Treatment:

Drug: brentuximab vedotin

Drug: brentuximab vedotin

Drug: midazolam

2

Experimental group

Description:

brentuximab vedotin +/- rifampin

Treatment:

Drug: rifampin

Drug: brentuximab vedotin

Drug: brentuximab vedotin

3

Experimental group

Description:

brentuximab vedotin +/- ketoconazole

Treatment:

Drug: brentuximab vedotin

Drug: ketoconazole

Drug: brentuximab vedotin

4

Experimental group

Description:

special populations

Treatment:

Drug: brentuximab vedotin

Drug: brentuximab vedotin