A Study of MORAb-003 in Patients With Solid Tumor
A Phase 1 Study of MORAb-003 in Patients With Solid Tumor
1 other identifier
interventional
16
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2010
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 13, 2010
CompletedFirst Posted
Study publicly available on registry
January 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJune 11, 2020
February 1, 2014
3 years
January 13, 2010
June 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate dose-limiting toxicity and estimate maximum tolerated dose.
7 weeks
Study Arms (1)
MORAb-003
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (2)
Unknown Facility
Hidaka-shi, Saitama, Japan
Unknown Facility
Chuo-ku, Tokyo, Japan
Related Publications (1)
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 alpha 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.
PMID: 25380636DERIVED
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Chifumi Kitamura
JAC PCU Eisai Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2010
First Posted
January 14, 2010
Study Start
January 1, 2010
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
June 11, 2020
Record last verified: 2014-02