NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Patients with malignant soft tissue sarcomas of histological types that have been reported to carry chromosomal translocations
Date of first enrollment	31/05/2012
Target sample size	74
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 : ET-743 (initial dose 1.2 mg/m2) will be administered via a central venous line in 24 hours. Treatment cycle consists of 21 days.

Outcome(s)

Primary Outcome	Progression free survival RECIST ver.1.1
Secondary Outcome	Overall response rate, Disease control rate, Safety, Overall survival, PK parameter RECIST ver.1.1, CTCAE ver.4.03

Key inclusion & exclusion criteria

Age minimum	>= 19age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Any of TRS histopathologically confirmed at the study site - Unresponsiveness or intolerability to the standard chemotherapy regimens - Other
Exclude criteria	- Severe concurrent disease - Other