Text Size

Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This study is currently recruiting participants.
Verified May 2013 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01461538
First received: October 24, 2011
Last updated: May 30, 2013
Last verified: May 2013
History of Changes
  Purpose

This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.


Condition Intervention Phase
Acute Lymphoid Leukemia
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Multiple Myeloma
Solid Tumors
 Drug: brentuximab vedotin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Until disease progression or study closure, up to 29 months ] [ Designated as safety issue: No ]
  • Complete remission (CR) rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or study closure, up to 29 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Plasma concentration at end of infusion (Ceoi) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, 8, 12, 16, and at the end of treatment assessment: predose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab vedotin 1.8 mg/kg
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
 Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: SGN-35
Experimental: Brentuximab vedotin 2.4 mg/kg
Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
 Drug: brentuximab vedotin
2.4 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: SGN-35

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
  • Have failed, refused, or have been deemed ineligible for standard therapy
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70

Exclusion Criteria:

  • Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
  • History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
  • Evidence of active cerebral/meningeal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461538

Contacts
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Sharon Barkley     205-975-2008     Sharon.Barkley@ccc.uab.edu    
Principal Investigator: Andres Forero-Torres, MD            
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010-3000
Contact: Nancy Boonsawas     626-256-4673 ext 64175     NBoonsawas@coh.org    
Principal Investigator: Tanya Siddiqi            
PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists Recruiting
Oxnard, California, United States, 93030
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Lynn Kong, M.D.            
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: John M. Burke, M.D.            
United States, Florida
Ocala Oncology Center Recruiting
Ocala, Florida, United States, 34471
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Craig Reynolds, M.D.            
United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Somer LeAnn Case-Eads, MA     317-278-4923     somcase@indiana.edu    
Principal Investigator: Lawrence Einhorn, M.D.            
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: John Schulz     617-632-5623     John_Schulz@DFCI.HARVARD.EDU    
Principal Investigator: Geoffrey Shapiro, M.D., Ph.D            
United States, Minnesota
Minnesota Oncology Hematology P.A. Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Patrick Flynn, M.D.            
United States, New York
New York Oncology Hematology, P.C. Recruiting
Albany, New York, United States, 12206
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Lawrence Garbo, M.D.            
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106-5055
Contact: Laura Balint     216-983-3229     Laura.Balint@uhhospitals.org    
Principal Investigator: Afshin Dowlati, M.D.            
United States, Oregon
Willamette Valley Cancer and Research / USOR Recruiting
Eugene, Oregon, United States, 97401
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Jeff Sharman, M.D.            
Northwest Cancer Specialists, P.C. Recruiting
Tualatin, Oregon, United States, 97062
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Christopher A Yasenchak, M.D.            
United States, South Carolina
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Kristina Stoeppler-Biege     864-255-1517     kristina_stoeppler-biege@bshsi.org    
Principal Investigator: Gary Spitzer, M.D.            
United States, Texas
Texas Oncology - Bedford Recruiting
Bedford, Texas, United States, 76022
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Thomas Anderson, M.D.            
Texas Oncology - Medical City Dallas Recruiting
Dallas, Texas, United States, 75230
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Michael Savin, M.D.            
Texas Oncology - Dallas Presbyterian Recruiting
Dallas, Texas, United States, 75231
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Kristi McIntyre, M.D.            
Texas Oncology - Fort Worth 12th Avenue Recruiting
Fort Worth, Texas, United States, 76104
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Robert Ruxer, M.D.            
MD Anderson Cancer Center /The University of Texas Recruiting
Houston, Texas, United States, 77030
Contact: Cecilia Wilcox     713-792-4971     CWilcox@mdanderson.org    
Principal Investigator: Jorge Cortes, M.D.            
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4003
Contact: Roosevelt Anderson     713-563-3854     randerson@mdanderson.org    
Principal Investigator: Jennifer Wheler, M.D.            
Texas Oncology - Central Austin Cancer Center Recruiting
Round Rock, Texas, United States, 78731
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Beth Hellerstedt, M.D.            
Texas Oncology - Waco Recruiting
Waco, Texas, United States, 76712
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Carl Chakmakjian, D.O.            
United States, Virginia
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care Recruiting
Christianburg, Virginia, United States, 24073
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Jerome Goldschmidt, M.D.            
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Dipti Patel-Donnelly, M.D.            
United States, Washington
Puget Sound Cancer Centers Recruiting
Edmonds, Washington, United States, 98026
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Eileen Johnston, M.D.            
Cancer Care Northwest Recruiting
Spokane Valley, Washington, United States, 99216
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Hakan Kaya, M.D.            
Yakima Valley Memorial Hospital / North Star Lodge Recruiting
Yakima, Washington, United States, 98902
Contact: Christi Schany     281-863-6712     christi.schany@usoncology.com    
Principal Investigator: Thomas Boyd, M.D.            
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Tina Albertson, MD, PhD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01461538     History of Changes
Other Study ID Numbers: SGN35-013
Study First Received: October 24, 2011
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Acute Lymphoid Leukemia
Chronic Lymphocytic Leukemia
Acute Myeloid Leukemia
Multiple Myeloma
Solid Tumors
Antibodies, Monoclonal
 Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Immunotherapy
Monomethyl Auristatin E

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013