Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies
This study has been completed.
Sponsor:
Seattle Genetics, Inc.
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
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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
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 School of Medicine |
| 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 B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Hematologic Neoplasms Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, T-Cell Neoplasms by Site Hematologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013