A Study of MORAb-009 in Patients With Solid Tumor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01018784
First received: November 23, 2009
Last updated: December 3, 2012
Last verified: December 2012

November 23, 2009
December 3, 2012
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
To primarily evaluate anti-tumor efficacy in evaluable patients.To investigate pharmacokinetics. [ Time Frame: during study ] [ Designated as safety issue: No ]
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
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
May 2012
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
Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01018784
MORAB-009-J081-102
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Chifumi Kitamura Morphotek Clinical Development Section, JAC PCU
Eisai Inc.
December 2012

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