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A Study of MORAb-003 in Patients With Solid Tumor

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01049061
First received: January 13, 2010
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MORAb-003 in Patients With Solid Tumor

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins 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: 7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01049061     History of Changes
Other Study ID Numbers: MORAB-003-J081-102
Study First Received: January 13, 2010
Last Updated: December 12, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Cancer
FRα

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013