|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Seattle Genetics, Inc. |
|---|---|
| Collaborator: |
Genentech |
| Information provided by: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00079716 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
| 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.
|
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.
Eligibility| 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:
Contacts and Locations| 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. |
More Information
| Responsible Party: | Seattle Genetics, Inc. ( Nancy Whiting, PharmD ) |
| Study ID Numbers: | SG040-0001 |
| Study First Received: | March 11, 2004 |
| Last Updated: | September 8, 2009 |
| 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 |
|
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 |