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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00430846
First received: February 1, 2007
Last updated: June 6, 2013
Last verified: October 2011
  Purpose

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 Intervention Phase
Lymphoma, Non-Hodgkin
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Drug: SGN-35
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK profile [ Time Frame: 2 months after last dose ] [ Designated as safety issue: No ]
  • Immunogenicity (anti-SGN-35 antibodies) [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]
  • Anti-tumor activity [ Time Frame: 1 month after last dose ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: November 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: SGN-35
Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg
Other Name: brentuximab vedotin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430846

Locations
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.
Investigators
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 Early Recognition Center
Principal Investigator: John Leonard, MD Weill Medical College of Cornell University
Study Director: Dana Kennedy, PharmD Seattle Genetics, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00430846     History of Changes
Obsolete Identifiers: NCT00412282
Other Study ID Numbers: SG035-0001
Study First Received: February 1, 2007
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on August 20, 2014