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Completed

NCT Number: NCT01018784

A Study of MORAb-009 in Patients With Solid Tumor

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.

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Key information

Conditions

Cancer Mesothelin-positive Neoplasms

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sayama-shi, Osaka, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MORAb-009

Drug

MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.

Primary outcomes

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

    Time frame: 4 Weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Study of MORAb-009 in Patients With Solid Tumor

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Nov 25, 2009
Registry last updated
Jan 21, 2016

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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