YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access

Status:

NO_LONGER_AVAILABLE

YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access

Lead Sponsor:

University of Texas Southwestern Medical Center

Collaborating Sponsors:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Conditions:

Soft Tissue Sarcoma

Eligibility:

All Genders

18-90 years

Brief 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 (...

Detailed Description

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 do...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01427582

Last Update

September 1 2011

Active Locations (1)

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