search
Back to results

Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
brentuximab vedotin
rifampin
midazolam
ketoconazole
brentuximab vedotin
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinomas focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • City of Hope
  • Colorado Blood Cancer Institute
  • St. Francis Medical Group Oncology & Hematology Specialists
  • Karmanos Cancer Institute / Wayne State University
  • Hackensack University Medical Center
  • Seattle Cancer Care Alliance / University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

midazolam +/- brentuximab vedotin

brentuximab vedotin +/- rifampin

brentuximab vedotin +/- ketoconazole

special populations

Outcomes

Primary Outcome Measures

Midazolam blood concentrations +/- brentuximab vedotin
Brentuximab vedotin blood concentrations +/- rifampin
Brentuximab vedotin in urine, feces, and blood
Brentuximab vedotin blood concentrations in special populations
Brentuximab vedotin blood concentrations +/- ketoconazole

Secondary Outcome Measures

Incidence of adverse events and laboratory abnormalities

Full Information

First Posted
December 2, 2009
Last Updated
December 17, 2014
Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01026415
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
midazolam +/- brentuximab vedotin
Arm Title
2
Arm Type
Experimental
Arm Description
brentuximab vedotin +/- rifampin
Arm Title
3
Arm Type
Experimental
Arm Description
brentuximab vedotin +/- ketoconazole
Arm Title
4
Arm Type
Experimental
Arm Description
special populations
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
ADCETRIS; SGN-35
Intervention Description
1.8 mg/kg IV every 21 days
Intervention Type
Drug
Intervention Name(s)
rifampin
Intervention Description
600 mg/day PO
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
1 mg IV
Intervention Type
Drug
Intervention Name(s)
ketoconazole
Intervention Description
400 mg/day PO
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
SGN-35
Intervention Description
1.2 mg/kg IV every 21 days
Primary Outcome Measure Information:
Title
Midazolam blood concentrations +/- brentuximab vedotin
Time Frame
3 weeks
Title
Brentuximab vedotin blood concentrations +/- rifampin
Time Frame
6 weeks
Title
Brentuximab vedotin in urine, feces, and blood
Time Frame
1 week
Title
Brentuximab vedotin blood concentrations in special populations
Time Frame
3 weeks
Title
Brentuximab vedotin blood concentrations +/- ketoconazole
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events and laboratory abnormalities
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Manley, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
St. Francis Medical Group Oncology & Hematology Specialists
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Karmanos Cancer Institute / Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48209
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Seattle Cancer Care Alliance / University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23754575
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.
Results Reference
result
PubMed Identifier
22510871
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.
Results Reference
derived

Learn more about this trial

Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

We'll reach out to this number within 24 hrs