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NCT00210665 - 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 Treatme

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


Data Specification

Not Available


Annotated CRF

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Product Info

Generic Name
Trabectedin
Product Name
YONDELIS®
Therapeutic Area
Cancers and Other Neoplasms
Enrollment
1,803
% Female
59.0%
% White
88.0%
Product Class
Antineoplastic Agents
Sponsor Protocol Number
ET743-SAR-3002
Data Holder
Johnson & Johnson
Condition Studied
Sarcoma
Mean/Median Age (Years)
54.0

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.