Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

Phase 1

Completed

• Conditions: Lymphoma, Large-Cell, Anaplastic; Disease, Hodgkin; Neoplasms; Carcinomas; Lymphoma, Non-Hodgkin
• Interventions: Drug: ketoconazole; Drug: brentuximab vedotin; Drug: rifampin; Drug: midazolam

• Registration Number: NCT01026415
• Lead Sponsor: Seagen Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	ketoconazole	brentuximab vedotin +/- ketoconazole
4	brentuximab vedotin	special populations
1	brentuximab vedotin	midazolam +/- brentuximab vedotin
2	rifampin	brentuximab vedotin +/- rifampin
1	midazolam	midazolam +/- brentuximab vedotin
2	brentuximab vedotin	brentuximab vedotin +/- rifampin
3	brentuximab vedotin	brentuximab vedotin +/- ketoconazole

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events and laboratory abnormalities	6 weeks

Trial Locations

Locations (6)

City of Hope; 🇺🇸 Duarte, California, United States

Karmanos Cancer Institute / Wayne State University; 🇺🇸 Detroit, Michigan, United States

St. Francis Medical Group Oncology & Hematology Specialists; 🇺🇸 Indianapolis, Indiana, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Seattle Cancer Care Alliance / University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States