Trial Information

Summary: A Multicenter, OpenLabel SingleArm Study of YONDELIS (trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment.

The objective of this study is to facilitate access to trabectedin for eligible previously treated subjects with Soft Tissue Sarcoma, who cannot be expected to benefit from currently available therapeutic options for treatment but who may benefit from treatment with trabectedin. The patient will receive trabectedin i.v formulation through a period of 24 hours. Patients will also receive weekly evaluations.

Subjects must satisfy the following criteria:

• Male or female subject of =18 years of age.
• Unresectable histologically proven STS.
• Subjects must have relapsed or had progressive disease following standard of care treatment prior to enrollment.
• Recovered from toxic effects of prior therapies.
• Must have satisfactory laboratory results.
• Female subjects must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control.
• Subjects (or their legally acceptable representatives) must have signed an informed consent document.

• Less than 4 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent.
• Active viral hepatitis or chronic liver disease.
• Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias.
• Active infection.
• Female subject who is pregnant or breast-feeding.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.