A Study of MORAb-009 in Patients With Solid Tumor

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc. ( Eisai Co., Ltd. )

ClinicalTrials.gov Identifier:

NCT01018784

First received: November 23, 2009

Last updated: December 3, 2012

Last verified: December 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Cancer Mesothelin-positive	Drug: MORAb-009	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1 Study of MORAb-009 in Patients With Solid Tumor

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

To investigate dose-limiting toxicity and estimate maximum tolerated dose. [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The best overall response rate in the RECIST evaluation and the preliminary evaluation calculating the frequency of Completed response and Partial Response. [ Time Frame: During Study ] [ Designated as safety issue: No ]


Enrollment:	17
Study Start Date:	November 2009
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria;

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

Exclusion criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018784

Locations


Japan

Sayama-shi, Osaka, Japan

Sponsors and Collaborators

Eisai Co., Ltd.

Investigators


Study Director:	Chifumi Kitamura	Morphotek Clinical Development Section, JAC PCU

More Information

No publications provided


Responsible Party:	Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:	NCT01018784 History of Changes
Other Study ID Numbers:	MORAB-009-J081-102
Study First Received:	November 23, 2009
Last Updated:	December 3, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:


Cancer Mesothelin-positive

ClinicalTrials.gov processed this record on March 01, 2015

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