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Sponsored by: |
Morphotek |
Information provided by: | Morphotek |
ClinicalTrials.gov Identifier: | NCT00325494 |
The purpose of this study is to establish the safest doses of an investigational drug called MORAb-009 in subjects with pancreatic cancer, mesothelioma, or certain types of ovarian or lung cancer. MORAb-009 is a monoclonal antibody that is directed to an antigen on the surface of these cancers.
Condition | Intervention | Phase |
Pancreatic Cancer Mesothelioma Ovarian Cancer Non-Small Cell Lung Cancer |
Drug: MORAb-009 |
Phase I |
MedlinePlus related topics: | Cancer Lung Cancer Mesothelioma Ovarian Cancer Pancreatic Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-009, a Chimeric Monoclonal Antibody, in Subjects With Advanced Mesothelin-Expressing Tumors |
Estimated Enrollment: | 21 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | February 2008 |
MORAb-009 is a high-affinity monoclonal antibody raised against human mesothelin, a membrane glycoprotein thought to be involved in cell adhesion and tightly associated with a range of cancers. It has been shown that mesothelin is over-expressed in pancreatic cancers, mesotheliomas, and ovarian or mesothelin-expressing ovarian or non-small cell lung cancers, while showing little expression in normal tissues. Preclinical experiments indicate that MORAb-009 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the safety of MORAb-009 in subjects with mesothelin-expressing tumors, as well as to establish serum pharmacokinetics of the antibody, and to assess tumor antigens that may serve as predictors of a response to MORAb-009.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count ≥ 100 x 109/L; Hemoglobin ≥ 9 g/dL; Serum bilirubin ≤ 2.0 mg/dL; Aspartate transaminase (AST) ≤ 5 x upper limit of normal (ULN); Alanine transaminase (ALT) ≤ 5 x ULN; Alkaline Phosphatase ≤ 5 x ULN; Serum creatinine ≤ 2.0 mg/dL. If the elevations of liver functions are due to obstruction of the common bile duct extrinsic to the liver, the subject may be enrolled at the discretion of the investigator even if the elevations are greater than the limits above. Stenting to reduce liver functions to qualifying levels is permitted.
- Subject must be willing and able to provide written informed consent.
Exclusion Criteria:
United States, Maryland | |||||
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||
Baltimore, Maryland, United States, 21231 | |||||
National Cancer Institute | |||||
Bethesda, Maryland, United States, 20892-1922 | |||||
United States, Pennsylvania | |||||
Fox Chase Cancer Center | |||||
Philadelphia, Pennsylvania, United States, 19111 |
Morphotek |
Study Director: | Susan C. Weil, M.D. | Morphotek, Inc. |
Study ID Numbers: | MORAb-009-001 |
First Received: | May 11, 2006 |
Last Updated: | October 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00325494 |
Health Authority: | United States: Food and Drug Administration |
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