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Randomized Trial in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments. — TOMAS2  

Advanced Soft Tissue Sarcoma Clinical Trial

Official title:
Phase 2 Randomized Trial of Trabectedin + Olaparib vs. Trabectedin in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments.

Clinical Trial Summary

Phase II study in patient with advanced Soft Tissue Sarcoma (STS) patients who have already received or are not suitable, for a doxorubicin-based treatment.

Clinical Trial Description

Randomized, open-label, active-controlled, multicenter phase II clinical study. Patients will be randomly assigned in a 1:1 ratio to receive trabectedin 1.1 mg/m2 24-hour intravenous continuous infusion every 3 weeks with olaparib (per os) 150 mg twice a day versus trabectedin 1.5 mg/m2 intravenous 24-hour continuous infusion every 3 weeks until progression or unacceptable toxicity as second- or further-line treatment in a population of STS patients who have already received or are not suitable for a doxorubicin-based treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03838744
Study type Interventional
Source Italian Sarcoma Group
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 26, 2020
Completion date February 2025
View Details
See also
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