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YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01427582
First received: August 30, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Soft Tissue Sarcoma
 Drug: Trabectedin

Study Type: Expanded Access     What is Expanded Access?
Official Title: YONDELIS(Trabectedin) Single Patient Compassionate Use / Expanded Access in Soft Tissue Sarcoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Intervention Details:
    Drug: Trabectedin
    Trabectedin i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days
    Other Name: 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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427582

Locations
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Principal Investigator: John C. Bagwell, MD University of Texas
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01427582     History of Changes
Other Study ID Numbers: 05- EAP- STS
Study First Received: August 30, 2011
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Trabectedin
Antineoplastic Agents, Alkylating
 Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013