Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01026415

Collaborator

Millennium Pharmaceuticals, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

12.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Carcinomas Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Neoplasms	Drug: brentuximab vedotin Drug: rifampin Drug: midazolam Drug: ketoconazole Drug: brentuximab vedotin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 midazolam +/- brentuximab vedotin	Drug: brentuximab vedotin 1.8 mg/kg IV every 21 days Other Names: ADCETRIS; SGN-35 Drug: midazolam 1 mg IV
Experimental: 2 brentuximab vedotin +/- rifampin	Drug: brentuximab vedotin 1.8 mg/kg IV every 21 days Other Names: ADCETRIS; SGN-35 Drug: rifampin 600 mg/day PO
Experimental: 3 brentuximab vedotin +/- ketoconazole	Drug: ketoconazole 400 mg/day PO Drug: brentuximab vedotin 1.2 mg/kg IV every 21 days Other Names: SGN-35
Experimental: 4 special populations	Drug: brentuximab vedotin 1.2 mg/kg IV every 21 days Other Names: SGN-35

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Incidence of adverse events and laboratory abnormalities [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	Colorado Blood Cancer Institute	Denver	Colorado	United States	80218
3	St. Francis Medical Group Oncology & Hematology Specialists	Indianapolis	Indiana	United States	46237
4	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan	United States	48209
5	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
6	Seattle Cancer Care Alliance / University of Washington Medical Center	Seattle	Washington	United States	98109-1023