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
Phase 1
12 Years
N/A
12 Years
N/A
Not Enrolling
Both
Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
Both
Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of adverse events and laboratory abnormalities
Outcome Time Frame:
1 month after last dose
Safety Issue:
Yes
Principal Investigator
Dana Kennedy, PharmD
Investigator Role:
Study Director
Investigator Affiliation:
Seattle Genetics, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
SG035-0002
NCT ID:
NCT00649584
Start Date:
March 2008
Completion Date:
February 2010
Related Keywords:
- Disease, Hodgkin
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, Non-Hodgkin
- 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
- Hodgkin Disease
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Large-Cell, Anaplastic
Name | Location |
|---|---|
| Stanford University Medical Center | Stanford, California 94305-5408 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
| University of Miami | Miami, Florida 33136 |
