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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer
Mesothelin-positive
 Drug: MORAb-009
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MORAb-009 in Patients With Solid Tumor

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To investigate dose-limiting toxicity and estimate maximum tolerated dose. [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MORAb-009 Drug: MORAb-009
MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018784

Locations
Japan
Sayama-shi, Osaka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Chifumi Kitamura Morphotek Clinical Development Section, JAC PCU
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01018784     History of Changes
Other Study ID Numbers: MORAB-009-J081-102
Study First Received: November 23, 2009
Last Updated: December 3, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Cancer
Mesothelin-positive

ClinicalTrials.gov processed this record on May 19, 2013