- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01427582
YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access
YONDELIS(Trabectedin) Single Patient Compassionate Use / Expanded Access in Soft Tissue Sarcoma
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Principal Investigator: John C. Bagwell, MD, University of Texas
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05- EAP- STS
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 Soft Tissue Sarcoma
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OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
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CytRxUnknownUnresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced Soft Tissue SarcomaUnited States, Australia, Russian Federation, Hungary, India, Romania, Ukraine
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National Institutes of Health Clinical Center (CC)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma | Stage IVB Adult Soft Tissue Sarcoma
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University of WashingtonAadi Bioscience, Inc.Active, not recruitingAdvanced Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced 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)TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue SarcomaUnited States
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Centre Leon BerardNovartis; National Cancer Institute, FranceRecruitingAdvanced Soft-tissue Sarcoma | Metastatic Soft-tissue SarcomaFrance
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UNICANCERRecruitingAdvanced Soft-tissue Sarcoma | Metastatic Soft-tissue SarcomaFrance
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University of Colorado, DenverAgenus Inc.RecruitingAdvanced Soft Tissue Sarcoma | Metastatic Soft Tissue SarcomaUnited States
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Wake Forest University Health SciencesMerck Sharp & Dohme LLCCompletedSoft Tissue Sarcoma, Adult | Soft Tissue Sarcoma, ChildUnited States
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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PharmaMarCompletedRelapsed Ovarian CancerSpain, France, Italy, Belgium, Germany