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Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00430846
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : December 18, 2014
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Drug: SGN-35 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.
Study Start Date : November 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: SGN-35
Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg
Other Name: brentuximab vedotin

Primary Outcome Measures :
  1. Incidence of adverse events and laboratory abnormalities [ Time Frame: 1 month after last dose ]

Secondary Outcome Measures :
  1. PK profile [ Time Frame: 2 months after last dose ]
  2. Immunogenicity (anti-SGN-35 antibodies) [ Time Frame: 1 month after last dose ]
  3. Anti-tumor activity [ Time Frame: 1 month after last dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically confirmed CD30-positive hematologic malignancy.
  • Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
  • Patients must have measurable disease of at least 10mm as documented by radiographic technique.
  • Must be at least 18 years of age.

Exclusion Criteria:

  • Patients with current diagnosis of pcALCL (systemic ALCL eligible).
  • Patients with history of allogeneic stem cell transplant.
  • Patients who have had previous treatment with any anti-CD30 antibody.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00430846

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
United States, Texas
University of Texas/MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Seattle Genetics, Inc.
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Principal Investigator: Andres Forero, MD University of Alabama at Birmingham
Principal Investigator: Anas Younes, MD M.D. Anderson Cancer Center
Principal Investigator: Nancy Bartlett, MD Washington University School of Medicine
Principal Investigator: John Leonard, MD Weill Medical College of Cornell University
Study Director: Dana Kennedy, PharmD Seattle Genetics, Inc.

Additional Information:
Publications of Results:
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Responsible Party: Seattle Genetics, Inc. Identifier: NCT00430846     History of Changes
Obsolete Identifiers: NCT00412282
Other Study ID Numbers: SG035-0001
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014
Keywords provided by Seattle Genetics, Inc.:
Antibody-Drug Conjugate
Antibodies, Monoclonal
Lymphoma, Non-Hodgkin
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Hematologic Diseases
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Immunologic Factors
Physiological Effects of Drugs