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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Mesothelin-positive | Drug: MORAb-009 | Phase 1 |
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 |
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. |
- To investigate dose-limiting toxicity and estimate maximum tolerated dose. [ Time Frame: 4 Weeks ]
- 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 ]

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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 |
Inclusion criteria;
- Japanese male and female patients aged from 20 to less than 80 years at obtaining informed consent
- Patient with histologically or cytologically diagnosed solid tumor
- Patient who is mesothelin-positive confirmed by immunohistochemistry (IHC) (except for pancreatic cancer and mesothelioma that mesothelin-positive is frequently reported)
- Patient with solid tumor who is non responder to or resistant to standard therapy and has no other appropriate treatment
- Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group ECOG criteria
Exclusion criteria
- Brain metastasis presenting clinical symptoms or requiring medical treatment
- Serious and systemic infection requiring medical treatment
- History of hypersensitivity to protein formulations including monoclonal antibody
- With active multiple carcinoma (except for carcinoma in situ and intramucosal carcinoma)
- With celomic fluid (pleural effusion or ascites) uncontrolled by drainage, or with a large volume of celomic fluid

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
Japan | |
Sayama-shi, Osaka, Japan |
Study Director: | Chifumi Kitamura | Morphotek Clinical Development Section, JAC PCU |
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 |
Cancer Mesothelin-positive |