Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325494
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2006-05-11
Brief Title:
A Study of MORAb-009 in Subjects With Pancreatic Cancer Mesothelioma or Certain Types of Ovarian or Lung Cancer
Sponsor:
Morphotek
Organization:
Morphotek
Study Overview
Official Title:
A Study of the Safety Tolerability and Pharmacokinetics of MORAb-009 a Chimeric Monoclonal Antibody in Subjects With Advanced Mesothelin-expressing Tumors
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None