YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Trabectedin

Criteria

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