Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This study is currently recruiting participants.
Verified March 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01461538
First received: October 24, 2011
Last updated: March 27, 2014
Last verified: March 2014
  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
Anemia, Refractory, With Excess of Blasts
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:


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 ]
  • Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Through 3 weeks after dosing (1.8 and 2.4 mg/kg arms) ] [ Designated as safety issue: No ]
  • Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Through 1 week after dosing (1.2 mg/kg arm) ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (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: Adcetris; 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: Adcetris; SGN-35
Experimental: Brentuximab vedotin 1.2 mg/kg
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
Drug: brentuximab vedotin
1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
Other Name: Adcetris; 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: Dayle Craig    205-975-8080    dc0350@uab.edu   
Principal Investigator: Andres Forero-Torres, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010-3000
Contact: Ann Mamanee    626-256-4671 ext 60830    amamanee@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
Mayo Clinic Cancer Center Recruiting
Jacksonville, Florida, United States, 32224
Contact: Mayo Clinic Clinical Trials ReferralOffice    507-538-7623      
Principal Investigator: James Foran, MD         
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: Jon Thomas (JT) Diener    317-278-9576    jtdiener@iupui.edu   
Principal Investigator: Lawrence Einhorn, M.D.         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Matthew Milstein    617-632-6627    MatthewI_Milstein@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
St. Francis Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Kristina Stoeppler-Biege    864-255-1517    kristina_stoeppler-biege@bshsi.org   
Principal Investigator: Howland Crosswell, MD         
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 Denton South Recruiting
Denton, Texas, United States, 76210
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Sharad Jain, 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 Leukemia Group 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
Blacksburg, Virginia, United States, 24060
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: Neil Josephson, MD Seattle Genetics, Inc.
  More Information

No publications provided by Seattle Genetics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Acute Lymphoid Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Solid Tumors
Anemia, Refractory, with Excess of Blasts
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Immunotherapy
Monomethyl Auristatin E

Additional relevant MeSH terms:
Anemia
Anemia, Refractory
Anemia, Refractory, with Excess of Blasts
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014