YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access
|ClinicalTrials.gov Identifier: NCT01427582|
Recruitment Status : No longer available
First Posted : September 1, 2011
Last Update Posted : September 1, 2011
|Condition or disease||Intervention/treatment|
|Soft Tissue Sarcoma||Drug: Trabectedin|
The single patient treatment instructions for use are intended for a single patient with advanced soft tissue sarcoma. The patient will be treated with YONDELIS® (trabectedin) i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days, provided that he/she fulfills all eligibility criteria.
The patient may continue to receive therapy until there is evidence of disease progression or unacceptable toxicity. Safety will be evaluated and serious adverse events will be reported. Disease assessments will occur according to institutional practice.
|Study Type :||Expanded Access|
|Official Title:||YONDELIS(Trabectedin) Single Patient Compassionate Use / Expanded Access in Soft Tissue Sarcoma|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427582
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||John C. Bagwell, MD||University of Texas|