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YONDELIS(Trabectedin) Single Patient Compassionate Use / Expanded Access in Soft Tissue Sarcoma

18 Years
90 Years
Not Enrolling
Soft Tissue Sarcoma

Thank you

Trial Information

YONDELIS(Trabectedin) Single Patient Compassionate Use / Expanded Access in Soft Tissue Sarcoma

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.

Inclusion Criteria:

1. Signed informed consent.

2. 18 years-of-age or older.

3. Unresectable, advanced or metastatic, histologically proven soft tissue sarcoma.

4. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or better.

5. Hematologic variables:

- Hemoglobin ≥9 g/dL

- ANC ≥1,500/μL

- Platelet count ≥100,000/μL

6. Serum creatinine ≤ upper limit of normal (ULN)

7. 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

Exclusion Criteria:

1. 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.

2. Less than 4 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or
therapy with any investigational agent

3. Active viral hepatitis or chronic liver disease

4. Unstable cardiac condition, including congestive heart failure or angina pectoris,
myocardial infarction within 1 year before enrollment, uncontrolled arterial
hypertension or arrhythmias

5. Active infection

Type of Study:

Expanded Access

Study Design:


Principal Investigator

John C. Bagwell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas


United States: Food and Drug Administration

Study ID:

05- EAP- STS



Start Date:

Completion Date:

Related Keywords:

  • Soft Tissue Sarcoma
  • Sarcoma



University of Texas Southwestern Dallas, Texas  75390