Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026415
• Other study ID #: SGN35-008
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2009
• Last updated: December 17, 2014
• Start date: December 2009
• Est. completion date: May 2012

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• brentuximab vedotin
1.8 mg/kg IV every 21 days
• rifampin
600 mg/day PO
• midazolam
1 mg IV
• ketoconazole
400 mg/day PO
• brentuximab vedotin
1.2 mg/kg IV every 21 days

Locations

Country	Name	City	State
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	St. Francis Medical Group Oncology & Hematology Specialists	Indianapolis	Indiana
United States	Seattle Cancer Care Alliance / University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Midazolam blood concentrations +/- brentuximab vedotin		3 weeks	Yes
Primary	Brentuximab vedotin blood concentrations +/- rifampin		6 weeks	Yes
Primary	Brentuximab vedotin in urine, feces, and blood		1 week	Yes
Primary	Brentuximab vedotin blood concentrations in special populations		3 weeks	Yes
Primary	Brentuximab vedotin blood concentrations +/- ketoconazole		6 weeks	Yes
Secondary	Incidence of adverse events and laboratory abnormalities		6 weeks	Yes