Clinical trial NCT01026415: Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2009-12-04
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Midazolam blood concentrations +/- brentuximab vedotin
timeFrame: 3 weeks
measure: Brentuximab vedotin blood concentrations +/- rifampin
timeFrame: 6 weeks
measure: Brentuximab vedotin in urine, feces, and blood
timeFrame: 1 week
measure: Brentuximab vedotin blood concentrations in special populations
timeFrame: 3 weeks
measure: Brentuximab vedotin blood concentrations +/- ketoconazole
timeFrame: 6 weeks
Secondary outcomes:
measure: Incidence of adverse events and laboratory abnormalities
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Indianapolis
country: United States
facility: St. Francis Medical Group Oncology & Hematology Specialists
state: Indiana
city: Detroit
country: United States
facility: Karmanos Cancer Institute / Wayne State University
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance / University of Washington Medical Center
state: Washington
Study officials:
affiliation: Seagen Inc.
name: Thomas Manley, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.