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Sponsors and Collaborators: |
Seattle Genetics, Inc. Genentech |
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Information provided by: | Seattle Genetics, Inc. |
ClinicalTrials.gov Identifier: | NCT00079716 |
The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: SGN-40 (anti-huCD40 mAb) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma |
Enrollment: | 44 |
Study Start Date: | March 2004 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: SGN-40 (anti-huCD40 mAb)
0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29.
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This is an open-label, multi-dose, single-arm, phase I, dose-escalation study to define the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of SGN-40 in patients with refractory or recurrent multiple myeloma.
A minimum of three patients will be entered into each dose-level cohort. All patients will receive a dose-loading schedule during the first two weeks.
The maximum weekly dose will be 16mg/kg.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who have received any of the following must complete within the specified time frame below:
Exclusion Criteria:
United States, California | |
James R. Berenson M.D., Inc. | |
West Hollywood, California, United States, 90069 | |
United States, Colorado | |
Rocky Mountain Cancer Center | |
Denver, Colorado, United States, 80218 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Cornell University | |
New York, New York, United States, 10021 | |
United States, Ohio | |
The Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 |
Study Director: | Nancy Whiting, PharmD | Seattle Genetics, Inc. |
Responsible Party: | Seattle Genetics, Inc. ( Nancy Whiting, PharmD ) |
Study ID Numbers: | SG040-0001 |
Study First Received: | March 11, 2004 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00079716 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antigens, CD40 Antibody, Monoclonal Blood Coagulation Disorders Hematologic Diseases Hemorrhagic Disorders Hemostatic Disorders |
Immunoproliferative Disorders Lymphoproliferative Disorders Paraproteinemias Vascular Diseases Antibody-Dependent Cell Cytotoxicity |
Immunoproliferative Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders Recurrence |
Hemostatics Multiple Myeloma Antibodies, Monoclonal Antibodies Hemorrhagic Disorders Lymphoproliferative Disorders Immunoglobulins Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |