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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 by Eisai Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Sasaki Y, Miwa K, Yamashita K, Sunakawa Y, Shimada K, Ishida H, Hasegawa K, Fujiwara K, Kodaira M, Fujiwara Y, Namiki M, Matsuda M, Takeuchi Y, Katsumata N. A phase I study of farletuzumab, a humanized anti-folate receptor α monoclonal antibody, in patients with solid tumors. Invest New Drugs. 2015 Apr;33(2):332-40. doi: 10.1007/s10637-014-0180-8. Epub 2014 Nov 9.
||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.:
ClinicalTrials.gov processed this record on July 01, 2015