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YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01427582
First Posted: September 1, 2011
Last Update Posted: September 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
August 30, 2011
September 1, 2011
September 1, 2011
 
YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access
The YONDELIS (trabectedin) Single Patient Compassionate Use /Expanded Access program provides patients with advanced soft tissue sarcoma, who do not qualify for ongoing clinical trials with YONDELIS (trabectedin), access to this investigational treatment.

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.

Expanded Access
Drug: Trabectedin
Trabectedin i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days
Other Name: YONDELIS
Not Provided
 
No longer available
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01427582
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Principal Investigator: John C. Bagwell, MD University of Texas
University of Texas Southwestern Medical Center
August 2011