- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00210665
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
October 9, 2017 updated by: Janssen Research & Development, LLC
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
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.
Study Overview
Detailed Description
This is a multicenter, open-label (all people know the identity of the intervention), single-arm study.
It will consist of 2 Phases: a Screening Phase (up to 21 days before the first dose administration), and Treatment Phase (for patients meeting the continuation criteria).
During the Treatment Phase, patients will receive a dose of 1.5 mg/m2 trabectedin intravenous formulation administered as a 24-hour infusion on Day 1 of each suggested 21-day treatment cycle.
All patients will receive 20 mg dexamethasone (or corticosteroid equivalent to dexamethasone).
Number of cycles is not specified for this study.
Patients may continue to receive treatment as long as they obtain an overall clinical benefit, ie, until there is clear evidence of disease progression or unacceptable toxicity, as judged by the investigator.
Trabectedin is the first of a new class of antitumor agents.
Previous studies with trabectedin in patients who had been previously treated for soft tissue sarcoma have suggested that treatment with trabectedin resulted in tumor shrinkage, disease stabilization, and improved survival rates.
However, hematologic toxicity, hepatic toxicity, and renal impairment were also observed in these patients.
The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment in patients previously treated for soft tissue sarcoma who are not expected to benefit from currently available therapeutic options for treatment of soft tissue sarcoma.
Safety will be monitored throughout the study.
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Edmonton N/A, Canada
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Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Ontario
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Toronto, Ontario, Canada
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Tel Aviv, Israel
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Alaska
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Anchorage, Alaska, United States
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California
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San Diego, California, United States
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Santa Monica, California, United States
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Colorado
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Aurora, Colorado, United States
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Florida
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Daytona Beach, Florida, United States
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Hollywood, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Idaho
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Coeur d'Alene, Idaho, United States
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Illinois
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Park Ridge, Illinois, United States
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Iowa
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Iowa City, Iowa, United States
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Kansas
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Overland Park, Kansas, United States
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Kentucky
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Louisville, Kentucky, United States
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Louisiana
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Metairie, Louisiana, United States
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Maryland
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Baltimore, Maryland, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Minnesota
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Rochester, Minnesota, United States
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Missouri
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Saint Joseph, Missouri, United States
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Nebraska
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Omaha, Nebraska, United States
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New Jersey
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Newark, New Jersey, United States
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New York
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New York, New York, United States
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Ohio
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Cleveland, Ohio, United States
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Oklahoma
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Tulsa, Oklahoma, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Texas
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Houston, Texas, United States
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San Antonio, Texas, United States
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Washington
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Seattle, Washington, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Charytonowicz 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Actual)
October 10, 2017
Last Update Submitted That Met QC Criteria
October 9, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR003583
- ET743SAR3002 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma
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Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage IIA Uterine Sarcoma | Stage IIB Uterine Sarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine Sarcoma | Stage IA Uterine Sarcoma | Stage IB Uterine Sarcoma | Stage IC Uterine SarcomaUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
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National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
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National Cancer Institute (NCI)RecruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Metastatic Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Unresectable SarcomaUnited States
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National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
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Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
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Brown UniversityActuate Therapeutics Inc.WithdrawnSoft Tissue Sarcoma | Osteosarcoma | Ewing Sarcoma of Bone | Leiomyosarcoma | High Grade Sarcoma | Liposarcoma | Rhabdomyosarcoma | Angiosarcoma | Bone Sarcoma | Synovial Sarcoma | Undifferentiated Pleomorphic Sarcoma | Myxofibrosarcoma | Spindle Cell SarcomaUnited States
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Epizyme, Inc.RecruitingAdvanced Soft-tissue Sarcoma | Advanced Epithelioid SarcomaUnited States, Taiwan, Canada, United Kingdom
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Centre Oscar LambretFrench Sarcoma Group; Study Group of Bone TumorsCompletedSoft Tissue Sarcoma | Uterine SarcomaFrance
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Advenchen Laboratories, LLCActive, not recruitingLeiomyosarcoma | Synovial Sarcoma | Alveolar Soft Part Sarcoma | Soft-Tissue SarcomaUnited States, United Kingdom, Spain, China, Italy
Clinical Trials on Trabectedin
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Italian Sarcoma GroupAstraZeneca; PharmaMarActive, not recruitingAdvanced Soft Tissue SarcomaItaly
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Italian Sarcoma GroupPharmaMarWithdrawnLeiomyosarcoma | Liposarcoma | Synovial SarcomaItaly
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PharmaMar, SpainCompletedSoft Tissue SarcomaGermany
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Gynecologic Oncology GroupNational Cancer Institute (NCI)Completed
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedSarcomaUnited States
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European Organisation for Research and Treatment...CompletedSarcoma | Small Intestine Cancer | Ovarian Cancer | Brain and Central Nervous System Tumors | Endometrial Cancer | Gastrointestinal Stromal Tumor
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European Organisation for Research and Treatment...CompletedUnspecified Adult Solid Tumor, Protocol SpecificFrance, Spain, Denmark, Netherlands, Norway, Belgium, United Kingdom, Israel, Italy, Switzerland, Germany, Austria, Greece, Portugal
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University of Colorado, DenverWithdrawn
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Grupo Español de Investigación en Cáncer de OvarioCompleted
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Suriya YessentayevaJohnson & JohnsonUnknown