A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive 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: NCT00649584
Recruitment Status : Terminated (Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy.)
First Posted : April 1, 2008
Last Update Posted : December 18, 2014
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies
Study Start Date : March 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: 1
SGN-35 alone or in combination with gemcitabine
Drug: SGN-35
IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles
Other Name: brentuximab vedotin
Drug: gemcitabine
IV; 1000 mg/m2 weekly 3 out of 4 weeks
Other Name: Gemzar

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

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed CD30-positive hematologic malignancy.
  • Patients with HL must have failed systemic chemotherapy.
  • Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
  • Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.

Exclusion Criteria:

  • Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
  • 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): NCT00649584

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94305
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4003
Sponsors and Collaborators
Seattle Genetics, Inc.
Study Director: Dana Kennedy, PharmD Seattle Genetics, Inc.

Publications of Results:
Responsible Party: Seattle Genetics, Inc. Identifier: NCT00649584     History of Changes
Other Study ID Numbers: SG035-0002
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by Seattle Genetics, Inc.:
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
monomethyl auristatin E
Combined Modality Therapy
Drug Therapy
Lymphoma, Non-Hodgkin
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Hematologic Diseases

Additional relevant MeSH terms:
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
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs