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Sponsored by: |
Immunomedics, Inc. |
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Information provided by: | Immunomedics, Inc. |
ClinicalTrials.gov Identifier: | NCT00597129 |
Safety study to determine highest dose of 90Y-hPAM4 can be safety administered
Condition | Intervention | Phase |
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Pancreatic Cancer |
Biological: 90Y-hPAM4 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I, Dose-Escalating Study to Investigate the Safety, Tolerability, Pharmacokinetics and Dosimetry of a Single Dose of 90YHumanized PAM4 IgG in Patients With Locally Advanced/Metastatic Pancreatic Cancer |
Enrollment: | 21 |
Study Start Date: | August 2004 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Multi Dose levels: Experimental
different doses of 90YhPAM4 will be given only once.
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Biological: 90Y-hPAM4
Single dose of 90Y-hPAM4 will be given and all patients will be followed for 12 weeks.
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radiolabeled anti-MUC1 humanized antibody) administered intravenously as a single dose to patients with locally advanced and/or metastatic pancreatic cancer. The primary objective is to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of 90Y-hPAM4 in this population. Secondary objectives include the assessment of tumor targeting, biodistribution, organ dosimetry and pharmacokinetics (PK) of 90Y-hPAM4 as determined by pre-therapy administration of 111In-hPAM4, the assessment of the antigenicity of 90Y-hPAM4, as determined by development of human anti-humanized antibodies (HAHA), and to obtain preliminary information on the efficacy of single dose 90Y-hPAM4 in this patient population.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Indiana | |
Goshen Cancer Center | |
Goshen, Indiana, United States, 46526 | |
United States, Nebraska | |
Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 | |
United States, New Jersey | |
University of Medicine and Dentistry | |
Newark, New Jersey, United States, 07101 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 |
Study Chair: | William Wegener, MD, PhD | Immunomedics, Inc. |
Responsible Party: | Immunomedics, Inc. ( William Wegener, MD, PHD ) |
Study ID Numbers: | IM-T-hPAM4-01 |
Study First Received: | January 8, 2008 |
Last Updated: | January 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00597129 |
Health Authority: | United States: Food and Drug Administration |
pancreatic cancer cancer of the pancreas pancreas cancer |
Antibodies Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Pancrelipase Immunoglobulins Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site |