A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment
A Multicenter, Open-Label, Single-Arm Study of YONDELIS (Trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment
2 other identifiers
expanded_access
N/A
3 countries
36
Brief Summary
The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
36 active sites
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
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedOctober 10, 2017
October 1, 2017
September 13, 2005
October 9, 2017
Conditions
Keywords
Interventions
Type= exact number, unit= mg/m2, number= 1.5, form= intravenous infusion, route= intravenous use. 1.5mg/m2 as 24hr infusion on day 1 of each 21 day cycle
Eligibility Criteria
You may qualify if:
- Unresectable advanced or metastatic histologically proven soft tissue sarcoma (STS). Eligibility will include adult participants with desmoplastic small round cell tumor
- Must have relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment or intolerant to prior standard of care treatment with chemotherapy due to safety issues
- Recovery from toxic effects of prior therapies to Grade 1 or better according to National Cancer Institute-Common Terminology Criteria of Adverse Events (criteria used to grade the severity of toxic effects on a scale from 0 to 5 - Grade 1 = mild in severity, Grade 0 = no severity)
- Clinical test results within acceptable limits (ie, hematologic, clinical chemistry and hepatic function test results)
- Female participants must be postmenopausal, surgically sterile, abstinent, or if sexually active, be practicing 2 effective methods of birth control (eg, prescription hormonal contraceptive, intrauterine device, double-barrier method \[eg, condoms, occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, cream, gel, film, or suppository\]), before entry, and must agree to continue to use these same methods of contraception throughout the study and for 3 months thereafter. Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm for a minimum of 5 months after treatment discontinuation
You may not qualify if:
- Diagnosis of Ewing's sarcoma or osteosarcoma, less than 3 weeks from last dose of radiation, systemic cytotoxic therapy (or 4 half lives, whichever is longer)
- Active symptomatic viral hepatitis or chronic liver disease
- Significant uncontrolled cardiac condition, including New York Heart Association Class II or greater heart failure, uncontrolled angina pectoris, myocardial infarction within 6 months before enrollment, significant pericardial disease, or uncontrolled or arrhythmias
- Active infection
- Female participant who is pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Anchorage, Alaska, United States
Unknown Facility
San Diego, California, United States
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Santa Monica, California, United States
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Aurora, Colorado, United States
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Daytona Beach, Florida, United States
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Hollywood, Florida, United States
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Atlanta, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Park Ridge, Illinois, United States
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Iowa City, Iowa, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Saint Joseph, Missouri, United States
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Omaha, Nebraska, United States
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Newark, New Jersey, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Toronto, Ontario, Canada
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Edmonton, Canada
Unknown Facility
Tel Aviv, Israel
Related Publications (2)
Samuels BL, Chawla S, Patel S, von Mehren M, Hamm J, Kaiser PE, Schuetze S, Li J, Aymes A, Demetri GD. Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study. Ann Oncol. 2013 Jun;24(6):1703-9. doi: 10.1093/annonc/mds659. Epub 2013 Feb 5.
PMID: 23385197DERIVEDCharytonowicz E, Terry M, Coakley K, Telis L, Remotti F, Cordon-Cardo C, Taub RN, Matushansky I. PPARgamma agonists enhance ET-743-induced adipogenic differentiation in a transgenic mouse model of myxoid round cell liposarcoma. J Clin Invest. 2012 Mar;122(3):886-98. doi: 10.1172/JCI60015. Epub 2012 Feb 1.
PMID: 22293175DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC & Development, L.L.C. Clinical Trial
Janssen Research & Development, LLC