NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080221134

Registered date:22/06/2010

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedSoft tissue sarcoma
Date of first enrollment22/06/2010
Target sample size
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : ET-743 INN of investigational material : trabectedin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : intravenous administration, One of three doses; 0.9mg/m2, 1.2mg/m2, 1.5mg/m2 (Based on the body surface area).

Outcome(s)

Primary OutcomeSafety
Secondary OutcomePharmacokinetics, Safety, Efficacy

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1)Patients who have a histologically confirmed soft tissue sarcoma. 2)Patients who have failed the standard therapy. 3)Others.
Exclude criteria1)Serious concomitant illness. 2)Prior therapy-related toxicity. 3)Others.

Related Information

Contact

Public contact
Name
Address toiawase@taiho.co.jp
Telephone
E-mail
Affiliation Taiho Pharmaceutical Co.,Ltd.
Scientific contact
Name
Address toiawaseCD1@taiho.co.jp
Telephone
E-mail
Affiliation Taiho Pharmaceutical Co.,Ltd.