Trabectedin First Line Therapy In Unfit Sarcoma Study

NCT02066675 ↗

Phase 2 Completed 24 enrolled Italian Sarcoma Group

NaSingle-groupOpen-labelTreatment

Summary

Phase II, non-randomized, two-stage study according to Bryant \& Day The study enroll patients with Metastatic and locally advanced soft tissue sarcoma unfit to receive standard chemotherapy (doxorubicin/epirubicin and/or ifosfamide)

Timeline

Start: 2014-02
Primary completion: 2016-12-31
Completion: 2016-12-31

Publications

Background Fayette J, Coquard IR, Alberti L, Boyle H, Meeus P, Decouvelaere AV, Thiesse P, Sunyach MP, Ranchere D, Blay JY. ET-743: a novel agent with activity in soft-tissue sarcomas. Curr Opin Oncol. 2006 Jul;18(4):347-53. doi: 10.1097/01.cco.0000228740.70379.3f.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trabectedin	Small molecule	1.3 mg/m2	Intravenous
Subject	Trabectedin	Small molecule	1.5 mg/m2	Intravenous

Indications

No indication recorded.