A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies
This study has been terminated.
(Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy.)
Sponsor:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00649584
First received: March 27, 2008
Last updated: October 7, 2011
Last verified: October 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin |
Drug: SGN-35 Drug: gemcitabine |
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 Weekly SGN-35 Monotherapy and in Combination With Gemcitabine 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: | 44 |
| Study Start Date: | March 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649584
Locations
| 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.
Investigators
| Study Director: | Dana Kennedy, PharmD | Seattle Genetics, Inc. |
More Information
No publications provided
| Responsible Party: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00649584 History of Changes |
| Other Study ID Numbers: | SG035-0002 |
| Study First Received: | March 27, 2008 |
| Last Updated: | October 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seattle Genetics, Inc.:
|
Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal monomethyl auristatin E Combined Modality Therapy Drug Therapy |
Immunotherapy 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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell Gemcitabine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 23, 2013