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A Study of MORAb-009 in Patients With Solid Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018784
First Posted: November 25, 2009
Last Update Posted: January 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
November 23, 2009
November 25, 2009
January 21, 2016
November 2009
May 2012   (Final data collection date for primary outcome measure)
To investigate dose-limiting toxicity and estimate maximum tolerated dose. [ Time Frame: 4 Weeks ]
Same as current
Complete list of historical versions of study NCT01018784 on ClinicalTrials.gov Archive Site
The best overall response rate in the RECIST evaluation and the preliminary evaluation calculating the frequency of Completed response and Partial Response. [ Time Frame: During Study ]
To primarily evaluate anti-tumor efficacy in evaluable patients.To investigate pharmacokinetics. [ Time Frame: During Study ]
Not Provided
Not Provided
 
A Study of MORAb-009 in Patients With Solid Tumor
A Phase 1 Study of MORAb-009 in Patients With Solid Tumor
MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cancer
  • Mesothelin-positive
Drug: MORAb-009
MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.
Experimental: MORAb-009
Intervention: Drug: MORAb-009
Fujisaka Y, Kurata T, Tanaka K, Kudo T, Okamoto K, Tsurutani J, Kaneda H, Okamoto I, Namiki M, Kitamura C, Nakagawa K. Phase I study of amatuximab, a novel monoclonal antibody to mesothelin, in Japanese patients with advanced solid tumors. Invest New Drugs. 2015 Apr;33(2):380-8. doi: 10.1007/s10637-014-0196-0. Epub 2014 Dec 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
February 2013
May 2012   (Final data collection date for primary outcome measure)

Inclusion criteria;

  1. Japanese male and female patients aged from 20 to less than 80 years at obtaining informed consent
  2. Patient with histologically or cytologically diagnosed solid tumor
  3. Patient who is mesothelin-positive confirmed by immunohistochemistry (IHC) (except for pancreatic cancer and mesothelioma that mesothelin-positive is frequently reported)
  4. Patient with solid tumor who is non responder to or resistant to standard therapy and has no other appropriate treatment
  5. Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group ECOG criteria

Exclusion criteria

  1. Brain metastasis presenting clinical symptoms or requiring medical treatment
  2. Serious and systemic infection requiring medical treatment
  3. History of hypersensitivity to protein formulations including monoclonal antibody
  4. With active multiple carcinoma (except for carcinoma in situ and intramucosal carcinoma)
  5. With celomic fluid (pleural effusion or ascites) uncontrolled by drainage, or with a large volume of celomic fluid
Sexes Eligible for Study: All
20 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01018784
MORAB-009-J081-102
Not Provided
Not Provided
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Chifumi Kitamura Morphotek Clinical Development Section, JAC PCU
Eisai Inc.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP