NIPH Clinical Trials Search

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Soft tissue sarcomas
Date of first enrollment	10/02/2016
Target sample size	140
Countries of recruitment
Study type	Observational
Intervention(s)	investigational material(s) Generic name etc : Yondelis I.V. infusion 0.25 mg/1 mg INN of investigational material : Trabectedin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : The usual dose of Yondelis for adults is 1.2 mg/m2 (body surface area) as trabectedin, administered once as an intravenous infusion over 24 hours, and the administration is withdrawn for at least 20 days. This constitutes one cycle of treatment, and treatment will be repeated in cycles. Dose may be reduced depending on the condition of each patient.

Outcome(s)

Primary Outcome	Safety Logistic regression
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	All patients receiving Yondelis
Exclude criteria