Trabectedin for Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
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- STATUS
- Recruiting
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- participants needed
- 1200
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- sponsor
- University of Medicine and Dentistry New Jersey
Summary
The objective of this study is to facilitate access to trabectedin for eligible previously treated subjects with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options for treatment of STS but who may benefit from treatment with trabectedin.
Description
This study is designed to accommodate individual requests for treatment with trabectedin before the drug becomes commercially available. In regions where trabectedin becomes commercially available and reimbursable in that particular country, an administrative cutoff for further accrual will be set. Subjects with STS who have relapsed following standard of care treatment or who are refractory to or intolerant of standard therapies but who may benefit from treatment may participate in this study. The safety profile of the drug will be further evaluated. Eligible subjects will receive a dose of 1.5 mg/m2 trabectedin intravenous (i.v.) formulation administered as a 24-hour infusion on Day 1 of each 17- to 49-day treatment cycle. Tumor assessment will be performed prior to administration of the first dose (Cycle 1, Day 1) and thereafter approximately every 2 cycles according to institutional standards. The number of cycles is not specified for this study. Subjects may continue to receive treatment as long as they derive an overall clinical benefit, i.e., until there is clear evidence of disease progression or unacceptable toxicity, as judged by the investigator. Safety evaluation will include physical examinations, monitoring vital signs and adverse events, and collecting hematology and clinical chemistry test results. Minimal efficacy data will be collected and includes tumor assessments and survival information. An administrative cutoff for further study accrual will be set in regions where trabectedin commercially becomes available and reimbursable in that particular country if applicable.
Details
| Condition | Sarcoma |
|---|---|
| Treatment | trabectedin |
| Clinical Study Identifier | NCT00707109 |
| Sponsor | University of Medicine and Dentistry New Jersey |
| Last Modified on | 7 November 2020 |
Eligibility
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