A Study of MORAb-003 in Patients With Solid Tumor
This study has been completed.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: January 13, 2010
Last updated: February 20, 2014
Last verified: February 2014
MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.
Patients With a Folate-receptor Alpha Expressing Solid Tumor Who Are Not Responsive or Resistant to Standard Therapy and Have no Other Appropriate Treatment.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 1 Study of MORAb-003 in Patients With Solid Tumor
Primary Outcome Measures:
- To investigate dose-limiting toxicity and estimate maximum tolerated dose. [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2013 (Final data collection date for primary outcome measure)
MORAb-003 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
|Ages Eligible for Study:
||20 Years to 79 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Japanese male and female aged >or=20 to <80 years at obtaining informed consent
- Patient with histologically or cytologically diagnosed solid tumor
- Patient who is FRα-positive confirmed by immunohistochemistry (IHC) (except for ovarian cancer that FRα-positive is frequently reported)
- Patients with a folate-receptor alpha expressing solid tumor who are not responsive or resistant to standard therapy and have no other appropriate treatment
- Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group（ECOG）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 other active malignancy (except for carcinoma in situ)
- With a large volume of pleural effusion or ascites requiring drainage
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01049061
|Hidaka-shi, Saitama, Japan |
|Chuo-ku, Tokyo, Japan |
Eisai Co., Ltd.
||JAC PCU Eisai Co., Ltd.
No publications provided
||Eisai Inc. ( Eisai Co., Ltd. )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 13, 2010
||February 20, 2014
||Japan: Ministry of Health, Labor and Welfare
Keywords provided by Eisai Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 01, 2014