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Sponsored by: |
PDL BioPharma, Inc. |
Information provided by: | PDL BioPharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00738764 |
This is a phase 1, multicenter, open-label, dose escalation trial of PDL192 in subjects with advanced solid tumors.
Condition | Intervention | Phase |
Cancer |
Biological: PDL192 |
Phase I |
MedlinePlus related topics: | Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Multicenter, Open-Label, Dose Escalation Trial of PDL192 in Subjects With Advanced Solid Tumors |
Estimated Enrollment: | 48 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
PDL192
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Biological: PDL192
Humanized anti-TWEAK receptor monoclonal IgG1 antibody
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The primary study objective is to determine the maximum tolerated dose of PDL192 in subjects with advanced solid tumors.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
Exclusion Criteria:
Subjects will be ineligible for this study if they meet any one of the following criteria:
Abnormal hematologic values defined as:
Abnormal kidney, liver, or pancreatic function defined as:
Contact: Abbie Oey | 650-454-2472 | abbbie.oey@pdl.com |
United States, Arizona | |||||
TGen Clinical Research Services at Scottsdale Healthcare | Recruiting | ||||
Scottsdale, Arizona, United States, 85258 | |||||
Contact: Joyce Ingold 480-323-1339 jingold@shc.org | |||||
United States, Colorado | |||||
Anschutz Cancer Pavilion | Recruiting | ||||
Aurora, Colorado, United States, 80045 | |||||
Contact: Stacy Grolinic 720-848-0655 stacy.grolnic@ucdenver.edu |
PDL BioPharma, Inc. |
Principal Investigator: | Daniel D. Von Hoff, MD, FACP | TGen Clinical Research Services at Scottsdale Healthcare |
Principal Investigator: | S. Gail Eckhardt, MD | University of Colorado at Denver and Health Sciences Center |
Responsible Party: | PDL BioPharma, Inc. ( Sheldon Mullins ) |
Study ID Numbers: | PDL192-1801 |
First Received: | August 18, 2008 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00738764 |
Health Authority: | United States: Food and Drug Administration |
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