YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access
NO_LONGER_AVAILABLE
Conditions studied: Soft Tissue Sarcoma
In brief
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.
Key facts
- Study ID
- NCT01427582
- Run by
- University of Texas Southwestern Medical Center
- Last updated by the study team
- 2011-09-01
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent.
- 18 years-of-age or older.
- Unresectable, advanced or metastatic, histologically proven soft tissue sarcoma.
- Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or better.
- Hematologic variables:
- Hemoglobin ≥9 g/dL
- ANC ≥1,500/μL
- Platelet count ≥100,000/μL
- Serum creatinine ≤ upper limit of normal (ULN)
- Hepatic function variables:
- Total bilirubin ≤ ULN
- Total alkaline phosphatase ≤ ULN, or if > ULN, then alkaline phosphatase liver fraction or 5'-nucleotidase must be ≤ ULN.
- AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be ≤ 2.5xULN
- Albumin ≥2.5 g/dL
You may not qualify if…
- Pregnant or breast-feeding women, or patients (male or female) not employing adequate contraception. Acceptable means of birth control include IUD, oral contraceptive, subdermal implant, and a condom with a contraceptive sponge or suppository.
- 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
Where it is running
- University of Texas Southwestern — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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