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| Sponsor: | Morphotek |
|---|---|
| Information provided by: | Morphotek |
| ClinicalTrials.gov Identifier: | NCT00325494 |
Purpose
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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:
Contacts and Locations| 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 | |
| Study Director: | Susan C. Weil, M.D. | Morphotek, Inc. |
More Information
| ClinicalTrials.gov Identifier: | NCT00325494 History of Changes |
| Obsolete Identifiers: | NCT00377013, NCT00349154 |
| Other Study ID Numbers: | MORAb-009-001 |
| Study First Received: | May 11, 2006 |
| Last Updated: | December 2, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Pancreatic Cancer Mesothelioma Ovarian Cancer Non-Small Cell Lung Cancer Mesothelin |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Mesothelioma Ovarian Neoplasms Pancreatic Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Adenoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Digestive System Neoplasms Digestive System Diseases Pancreatic Diseases |