A Study of MORAb-009 in Patients With Solid Tumor

Cancer Clinical Trial

Official title:

A Phase 1 Study of MORAb-009 in Patients With Solid Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018784
• Other study ID #: MORAB-009-J081-102
• Status: Completed
• Phase: Phase 1
• First received: November 23, 2009
• Last updated: January 19, 2016
• Start date: November 2009
• Est. completion date: February 2013

Study information

• Verified date: January 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

Inclusion criteria;

1. Japanese male and female patients aged from 20 to less than 80 years at obtaining informed consent

2. Patient with histologically or cytologically diagnosed solid tumor

3. Patient who is mesothelin-positive confirmed by immunohistochemistry (IHC) (except for pancreatic cancer and mesothelioma that mesothelin-positive is frequently reported)

4. Patient with solid tumor who is non responder to or resistant to standard therapy and has 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 active multiple carcinoma (except for carcinoma in situ and intramucosal carcinoma)

5. With celomic fluid (pleural effusion or ascites) uncontrolled by drainage, or with a large volume of celomic fluid

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Mesothelin-positive

Intervention

Drug:
• MORAb-009
MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.

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.		4 Weeks	Yes
Secondary	The best overall response rate in the RECIST evaluation and the preliminary evaluation calculating the frequency of Completed response and Partial Response.		During Study	No