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Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

NCT ID: NCT01026415

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Carcinomas Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Neoplasms

Keywords

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Antibody-Drug Conjugate Antigens, CD30 Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin monomethyl auristatin E Drug Therapy Immunotherapy Hematologic Diseases Lymphoma Antibodies, Monoclonal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

midazolam +/- brentuximab vedotin

Group Type EXPERIMENTAL

brentuximab vedotin

Intervention Type DRUG

1.8 mg/kg IV every 21 days

midazolam

Intervention Type DRUG

1 mg IV

2

brentuximab vedotin +/- rifampin

Group Type EXPERIMENTAL

brentuximab vedotin

Intervention Type DRUG

1.8 mg/kg IV every 21 days

rifampin

Intervention Type DRUG

600 mg/day PO

3

brentuximab vedotin +/- ketoconazole

Group Type EXPERIMENTAL

ketoconazole

Intervention Type DRUG

400 mg/day PO

brentuximab vedotin

Intervention Type DRUG

1.2 mg/kg IV every 21 days

4

special populations

Group Type EXPERIMENTAL

brentuximab vedotin

Intervention Type DRUG

1.2 mg/kg IV every 21 days

Interventions

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brentuximab vedotin

1.8 mg/kg IV every 21 days

Intervention Type DRUG

rifampin

600 mg/day PO

Intervention Type DRUG

midazolam

1 mg IV

Intervention Type DRUG

ketoconazole

400 mg/day PO

Intervention Type DRUG

brentuximab vedotin

1.2 mg/kg IV every 21 days

Intervention Type DRUG

Other Intervention Names

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ADCETRIS; SGN-35 SGN-35

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Manley, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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City of Hope

Duarte, California, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

St. Francis Medical Group Oncology & Hematology Specialists

Indianapolis, Indiana, United States

Site Status

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Seattle Cancer Care Alliance / University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Han TH, Gopal AK, Ramchandren R, Goy A, Chen R, Matous JV, Cooper M, Grove LE, Alley SC, Lynch CM, O'Connor OA. CYP3A-mediated drug-drug interaction potential and excretion of brentuximab vedotin, an antibody-drug conjugate, in patients with CD30-positive hematologic malignancies. J Clin Pharmacol. 2013 Aug;53(8):866-77. doi: 10.1002/jcph.116. Epub 2013 Jun 10.

Reference Type RESULT
PMID: 23754575 (View on PubMed)

Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.

Reference Type DERIVED
PMID: 22510871 (View on PubMed)

Other Identifiers

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SGN35-008

Identifier Type: -

Identifier Source: org_study_id