drugset / Trial / NCT02929394

Trabectedin Maintenance Post 1st-line in STS

NCT02929394

RandomizedParallel-groupOpen-labelTreatment

Summary

Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma. This is a prospective, multicenter, randomized, open label Phase III trial investigating whether a maintenance treatment with trabectedin, as compared to the observational approach, can prolong progression-free survival in patients with advanced, inoperable and/or metastatic STS after response or stabilisation during first line treatment with doxorubicin.

Timeline

Start
2017-11-07
Primary completion
2020-06-05
Completion
2020-06-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Trabectedin Small molecule 1.2 mg/m2 Intravenous

Indications