JRCT ID: jRCT2080221134
Registered date:22/06/2010
Basic Information
Recruitment status | |
---|---|
Health condition(s) or Problem(s) studied | Soft tissue sarcoma |
Date of first enrollment | 22/06/2010 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | Safety |
---|---|
Secondary Outcome | Pharmacokinetics, Safety, Efficacy |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
---|---|
Age maximum | Not applicable |
Gender | Both |
Include criteria | 1)Patients who have a histologically confirmed soft tissue sarcoma. 2)Patients who have failed the standard therapy. 3)Others. |
Exclude criteria | 1)Serious concomitant illness. 2)Prior therapy-related toxicity. 3)Others. |
Related Information
Primary Sponsor | Taiho Pharmaceutical Co., Ltd. |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | Taiho Pharmaceutical Co.,Ltd. |
Secondary ID(s) | JapicCTI-101169 |
Contact
Public contact | |
Name | |
Address | toiawase@taiho.co.jp |
Telephone | |
Affiliation | Taiho Pharmaceutical Co.,Ltd. |
Scientific contact | |
Name | |
Address | toiawaseCD1@taiho.co.jp |
Telephone | |
Affiliation | Taiho Pharmaceutical Co.,Ltd. |