A Study of MORAb-003 in Patients With Solid Tumor

Neoplasms Clinical Trial

Official title:

A Phase 1 Study of MORAb-003 in Patients With Solid Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049061
• Other study ID #: MORAB-003-J081-102
• Status: Completed
• Phase: Phase 1
• Start date: January 2010
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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 FRa-positive confirmed by immunohistochemistry (IHC) (except for ovarian cancer that FRa-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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• MORAb-003
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate dose-limiting toxicity and estimate maximum tolerated dose.		7 weeks