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	04/06/2012
Target sample size	37
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	Safety CTCAE ver.4.03
Secondary Outcome	Overall response rate, Disease control rate, Progression free survival, Overall survival RECIST ver.1.1

Key inclusion & exclusion criteria

Age minimum	>= 19age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Assignment to the best supportive care (BSC) group of the comparative study - Other
Exclude criteria	- Severe concurrent disease - Other