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Completed

NCT Number: NCT01026415

Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

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).

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Key information

Conditions

Carcinomas Carcinoma Disease, Hodgkin Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope, Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brentuximab Vedotin

Drug

1.8 mg/kg IV every 21 days

Other names: ADCETRIS; SGN-35

Rifampin

Drug

600 mg/day PO

midazolam

Drug

1 mg IV

Ketoconazole

Drug

400 mg/day PO

Primary outcomes

  1. Midazolam blood concentrations +/- brentuximab vedotin

    Time frame: 3 weeks

  2. Brentuximab vedotin blood concentrations +/- rifampin

    Time frame: 6 weeks

  3. Brentuximab vedotin in urine, feces, and blood

    Time frame: 1 week

  4. Brentuximab vedotin blood concentrations in special populations

    Time frame: 3 weeks

  5. Brentuximab vedotin blood concentrations +/- ketoconazole

    Time frame: 6 weeks

Secondary outcomes

  1. Incidence of adverse events and laboratory abnormalities

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 4, 2009
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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