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A Study of MORAb-003 in Patients With Solid Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01049061
First Posted: January 14, 2010
Last Update Posted: February 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  Purpose
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.

Condition Intervention Phase
Patients With a Folate-receptor Alpha Expressing Solid Tumor Who Are Not Responsive or Resistant to Standard Therapy and Have no Other Appropriate Treatment. Drug: MORAb-003 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MORAb-003 in Patients With Solid Tumor

Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

Primary Outcome Measures:
  • To investigate dose-limiting toxicity and estimate maximum tolerated dose. [ Time Frame: 7 weeks ]

Enrollment: 16
Study Start Date: January 2010
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MORAb-003 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049061


Locations
Japan
Hidaka-shi, Saitama, Japan
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Chifumi Kitamura JAC PCU Eisai Co., Ltd.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01049061     History of Changes
Other Study ID Numbers: MORAB-003-J081-102
First Submitted: January 13, 2010
First Posted: January 14, 2010
Last Update Posted: February 21, 2014
Last Verified: February 2014

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Cancer
FRα