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A Study of MORAb-009 in Patients With Solid Tumor

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ClinicalTrials.gov Identifier: NCT01018784
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Mesothelin-positive Drug: MORAb-009 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MORAb-009 in Patients With Solid Tumor
Study Start Date : November 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : February 2013
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. To investigate dose-limiting toxicity and estimate maximum tolerated dose. [ Time Frame: 4 Weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018784


Locations
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Japan
Sayama-shi, Osaka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Chifumi Kitamura Morphotek Clinical Development Section, JAC PCU
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01018784    
Other Study ID Numbers: MORAB-009-J081-102
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Cancer
Mesothelin-positive