A Study of MORAb-009 in Patients With Solid Tumor
A Phase 1 Study of MORAb-009 in Patients With Solid Tumor
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 cancer
Started Nov 2009
Typical duration for phase_1 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 23, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJanuary 21, 2016
January 1, 2016
2.5 years
November 23, 2009
January 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate dose-limiting toxicity and estimate maximum tolerated dose.
4 Weeks
Secondary Outcomes (1)
The best overall response rate in the RECIST evaluation and the preliminary evaluation calculating the frequency of Completed response and Partial Response.
During Study
Study Arms (1)
MORAb-009
EXPERIMENTALInterventions
MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.
Eligibility Criteria
You may qualify if:
- 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
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (1)
Unknown Facility
Sayama-shi, Osaka, Japan
Related Publications (1)
Fujisaka Y, Kurata T, Tanaka K, Kudo T, Okamoto K, Tsurutani J, Kaneda H, Okamoto I, Namiki M, Kitamura C, Nakagawa K. Phase I study of amatuximab, a novel monoclonal antibody to mesothelin, in Japanese patients with advanced solid tumors. Invest New Drugs. 2015 Apr;33(2):380-8. doi: 10.1007/s10637-014-0196-0. Epub 2014 Dec 12.
PMID: 25502863DERIVED
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Chifumi Kitamura
Morphotek Clinical Development Section, JAC PCU
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2009
First Posted
November 25, 2009
Study Start
November 1, 2009
Primary Completion
May 1, 2012
Study Completion
February 1, 2013
Last Updated
January 21, 2016
Record last verified: 2016-01