NCT01427582

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
Last Updated

September 1, 2011

Status Verified

August 1, 2011

First QC Date

August 30, 2011

Last Update Submit

August 30, 2011

Conditions

Soft Tissue Sarcoma

Interventions

TrabectedinDRUG

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

Also known as: YONDELIS

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • John C. Bagwell, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 1, 2011

Last Updated

September 1, 2011

Record last verified: 2011-08

Locations

US(1)