Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

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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)

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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