Back to resultsYONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access
Primary Purpose
Soft Tissue Sarcoma
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Trabectedin
Sponsored by
About this trial
This is an expanded access trial for Soft Tissue Sarcoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Texas Southwestern
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01427582
First Posted
August 30, 2011
Last Updated
August 30, 2011
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT01427582
Brief Title
YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access
Official Title
YONDELIS(Trabectedin) Single Patient Compassionate Use / Expanded Access in Soft Tissue Sarcoma
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Trabectedin
Other Intervention Name(s)
YONDELIS
Intervention Description
Trabectedin i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Bagwell, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access
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