Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

NCT01026415 | Completed Phase 1

• 1 other identifier: SGN35-008
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 6

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Incidence of adverse events and laboratory abnormalities

  6 weeks

Study Arms (4)

1

EXPERIMENTAL

midazolam +/- brentuximab vedotin

Drug: brentuximab vedotin; Drug: midazolam

2

EXPERIMENTAL

brentuximab vedotin +/- rifampin

Drug: brentuximab vedotin; Drug: rifampin

3

EXPERIMENTAL

brentuximab vedotin +/- ketoconazole

Drug: ketoconazole; Drug: brentuximab vedotin

4

EXPERIMENTAL

special populations

Drug: brentuximab vedotin

Interventions

brentuximab vedotin DRUG

1.8 mg/kg IV every 21 days

Also known as: ADCETRIS; SGN-35

1; 2

rifampin DRUG

600 mg/day PO

2

midazolam DRUG

1 mg IV

1

ketoconazole DRUG

400 mg/day PO

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seagen Inc.: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (6)

City of Hope

Duarte, California, 91010, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

St. Francis Medical Group Oncology & Hematology Specialists

Indianapolis, Indiana, 46237, United States

Location

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, 48209, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Seattle Cancer Care Alliance / University of Washington Medical Center

Seattle, Washington, 98109-1023, United States

Location

Related Publications (2)

• 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.

  PMID: 23754575 RESULT

• 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.

  PMID: 22510871 DERIVED

MeSH Terms

Conditions

Carcinoma; Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin; Neoplasms; Hematologic Diseases; Lymphoma

Interventions

Brentuximab Vedotin; Rifampin; Midazolam; Ketoconazole

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Piperazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Thomas Manley, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 4, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (6)