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
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ClinicalTrials.gov Identifier: NCT00210665 |
Expanded Access Status :
No longer available
First Posted : September 21, 2005
Last Update Posted : October 10, 2017
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Condition or disease | Intervention/treatment |
---|---|
Sarcoma | Drug: Trabectedin |
Study Type : | Expanded Access |
Official Title: | 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 |

- Drug: Trabectedin
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

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210665
United States, Alaska | |
Anchorage, Alaska, United States | |
United States, California | |
San Diego, California, United States | |
Santa Monica, California, United States | |
United States, Colorado | |
Aurora, Colorado, United States | |
United States, Florida | |
Daytona Beach, Florida, United States | |
Hollywood, Florida, United States | |
United States, Georgia | |
Atlanta, Georgia, United States | |
United States, Idaho | |
Coeur d'Alene, Idaho, United States | |
United States, Illinois | |
Park Ridge, Illinois, United States | |
United States, Iowa | |
Iowa City, Iowa, United States | |
United States, Kansas | |
Overland Park, Kansas, United States | |
United States, Kentucky | |
Louisville, Kentucky, United States | |
United States, Louisiana | |
Metairie, Louisiana, United States | |
United States, Maryland | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Boston, Massachusetts, United States | |
United States, Michigan | |
Ann Arbor, Michigan, United States | |
Detroit, Michigan, United States | |
United States, Minnesota | |
Rochester, Minnesota, United States | |
United States, Missouri | |
Saint Joseph, Missouri, United States | |
United States, Nebraska | |
Omaha, Nebraska, United States | |
United States, New Jersey | |
Newark, New Jersey, United States | |
United States, New York | |
New York, New York, United States | |
United States, Ohio | |
Cleveland, Ohio, United States | |
United States, Oklahoma | |
Tulsa, Oklahoma, United States | |
United States, Oregon | |
Portland, Oregon, United States | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States | |
United States, South Carolina | |
Charleston, South Carolina, United States | |
United States, Texas | |
Houston, Texas, United States | |
San Antonio, Texas, United States | |
United States, Washington | |
Seattle, Washington, United States | |
United States, Wisconsin | |
Milwaukee, Wisconsin, United States | |
Canada, Alberta | |
Calgary, Alberta, Canada | |
Edmonton, Alberta, Canada | |
Canada, Ontario | |
Toronto, Ontario, Canada | |
Canada | |
Edmonton N/A, Canada | |
Israel | |
Tel Aviv, Israel |
Study Director: | Janssen Research & Development, LLC & Development, L.L.C. Clinical Trial | Janssen Research & Development, LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT00210665 |
Obsolete Identifiers: | NCT00707109 |
Other Study ID Numbers: |
CR003583 ET743SAR3002 ( Other Identifier: Janssen Research & Development, LLC ) |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | October 10, 2017 |
Last Verified: | October 2017 |
Sarcoma Soft tissue sarcoma Standard care |
Trabectedin Antitumor agent Safety |
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Trabectedin |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |