A Study of MORAb-003 in Patients With Solid Tumor

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Farletuzumab

Criteria

Inclusion criteria;

1. Japanese male and female aged >or=20 to <80 years at obtaining informed consent

2. Patient with histologically or cytologically diagnosed solid tumor

3. Patient who is FRα-positive confirmed by immunohistochemistry (IHC) (except for ovarian cancer that FRα-positive is frequently reported)

4. Patients with a folate-receptor alpha expressing solid tumor who are not responsive or resistant to standard therapy and have no other appropriate treatment

5. Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group（ECOG）criteria

Exclusion criteria

1. Brain metastasis presenting clinical symptoms or requiring medical treatment

2. Serious and systemic infection requiring medical treatment

3. History of hypersensitivity to protein formulations including monoclonal antibody

4. With other active malignancy (except for carcinoma in situ)

5. With a large volume of pleural effusion or ascites requiring drainage