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


Phase 1
20 Years
79 Years
Open (Enrolling)
Both
Patients With a Folate-receptor Alpha Expressing Solid Tumor Who Are Not Responsive or Resistant to Standard Therapy and Have no Other Appropriate Treatment.

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To investigate dose-limiting toxicity and estimate maximum tolerated dose.

Outcome Time Frame:

7 weeks

Safety Issue:

Yes

Principal Investigator

Chifumi Kitamura

Investigator Role:

Study Director

Investigator Affiliation:

JAC PCU Eisai Co., Ltd.

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

MORAB-003-J081-102

NCT ID:

NCT01049061

Start Date:

January 2010

Completion Date:

December 2012

Related Keywords:

  • Patients With a Folate-receptor Alpha Expressing Solid Tumor Who Are Not Responsive or Resistant to Standard Therapy and Have no Other Appropriate Treatment.
  • Cancer
  • FRα
  • Neoplasms

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