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Trial Information
Generic NameTrabectedinProduct NameYONDELIS®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupPlant Alkaloids and Other Natural ProductsChemical SubgroupOther Plant Alkaloids and Natural ProductsCondition StudiedSarcoma
Sponsor Protocol NumberET743-SAR-3002Enrollment1803Data PartnerJohnson & Johnson% Female59%Mean/Median Age (Years)54% White88%
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0560 : Pooled analysis of the efficacy of trabectedin in myxoid/round cell liposarcoma from trabectedin registrational and open access clinical trials
- 2023-5195 : Predictive modeling of adverse events and symptoms patterns in large scale clinical trials
- 2020-4519 : Trabectedin: statistical modeling of expanded access programs and clinical trials.
- 2018-2946 : Safety of re-administration of trabectedin in soft tissue sarcoma patients experiencing CK elevation