- CSR Summary Not Yet Available
- NCT01343277
- Primary Citation
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Trial Information
Generic NameTrabectedinProduct NameYONDELIS®Therapeutic AreaCancers and Other NeoplasmsEnrollment577% Female70%% WhiteN/A
Product ClassAntineoplastic AgentsSponsor Protocol NumberET743-SAR-3007Data PartnerJohnson & JohnsonCondition StudiedLiposarcoma/Leiomyosarcoma, AdvancedMean/Median Age (Years)57
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
- 2022-4974 : Association between adverse events and change in quality-of-life scores in phase II-III cancer clinical trials
- 2022-4889 : Summarising the therapeutic and adverse effects of anticancer medicines according to race and sex: pooled analysis of 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