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Completed

NCT Number: NCT01049061

A Study of MORAb-003 in Patients With Solid Tumor

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.

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Key information

Conditions

Neoplasms Solid Tumor

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hidaka-shi, Saitama, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

;

  • Japanese male and female aged >or=20 to <80 years at obtaining informed consent
  • Patient with histologically or cytologically diagnosed solid tumor
  • Patient who is FRα-positive confirmed by immunohistochemistry (IHC) (except for ovarian cancer that FRα-positive is frequently reported)
  • Patients with a folate-receptor alpha expressing solid tumor who are not responsive or resistant to standard therapy and have 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 other active malignancy (except for carcinoma in situ)
  • With a large volume of pleural effusion or ascites requiring drainage

Treatment and study plan

MORAb-003

Drug

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

Primary outcomes

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

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 14, 2010
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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