An SGN-35 Trial for Patients Who Have Previously Participated in an SGN-35 Study
This study has been completed.
Sponsor:
Seattle Genetics, Inc.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00947856
First received: July 24, 2009
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with SGN-35 in patients who have previously participated in an SGN-35 study.
| Condition | Intervention | Phase |
|---|---|---|
|
Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin |
Drug: SGN-35 |
Phase 2 |
An investigational treatment associated with this study has been approved for sale to the public. More info ...
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study |
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: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
- Best clinical response [ Time Frame: Every 2 to 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of response, progression-free survival, and overall survival [ Time Frame: Every 3 months until death or study closure ] [ Designated as safety issue: No ]
- Incidence of antitherapeutic antibodies [ Time Frame: Up to 1 month post last dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 111 |
| Study Start Date: | July 2009 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
SGN-35
|
Drug: SGN-35
Every 21 days by intravenous infusion (1.2 or 1.8 mg/kg)
Other Name: brentuximab vedotin
|
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participated in a previous SGN-35 study.
- CD30-positive hematologic malignancy.
- At a minimum, experienced clinical benefit in the prior SGN-35 study. For retreatment, patients must have previously achieved either complete or partial remission with SGN-35 and experienced disease progression after discontinuing the prior SGN-35 study.
Exclusion Criteria:
Withdrew consent to participate in any prior SGN-35 study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947856
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, California | |
| City of Hope National Medical Center | |
| Duarte, California, United States, 91010 | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Colorado Blood Cancer Institute | |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| Loyola University Medical Center - Cardinal Bernadin Cancer Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| St. Francis Medical Group Oncology & Hematology Specialists | |
| Indianapolis, Indiana, United States, 46237 | |
| United States, Michigan | |
| Karmanos Cancer Institute / Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| The John Theurer Cancer Center, Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10019 | |
| NYU Clinical Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, Ohio | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| United States, Texas | |
| Charles A. Sammons Cancer Center | |
| Dallas, Texas, United States, 75246 | |
| MD Anderson Cancer Center /The University of Texas | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Seattle Cancer Care Alliance / University of Washington Medical Center | |
| Seattle, Washington, United States, 98109-1023 | |
| France | |
| Hopital Saint-Louis/Service d'Hematologie | |
| Paris, Cedex 10, France, 75475 | |
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Investigators
| Study Director: | Laurie Grove, PA-C | Seattle Genetics, Inc. |
More Information
No publications provided
| Responsible Party: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00947856 History of Changes |
| Other Study ID Numbers: | SGN35-006 |
| Study First Received: | July 24, 2009 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seattle Genetics, Inc.:
|
Antibodies, Monoclonal Antibody-Drug Conjugate Antigens, CD30 Drug Therapy |
Hematologic Diseases Immunotherapy Monomethylauristatin E |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell |
ClinicalTrials.gov processed this record on May 23, 2013