YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access

NCT ID: NCT01427582

Last Updated: 2011-09-01

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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 (trabectedin), access to this investigational treatment.

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 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.

Conditions

Soft Tissue Sarcoma

Interventions

Trabectedin

Trabectedin i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days

Intervention Type: DRUG

Other Intervention Names

YONDELIS

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John C. Bagwell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Southwestern

Dallas, Texas, United States

Countries

United States

Other Identifiers

05- EAP- STS

Identifier Type: -

Identifier Source: org_study_id