Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma
Status:
Completed
Trial end date:
2020-09-16
Target enrollment:
Participant gender:
Summary
This is an international (France, Austria and Germany), randomized, double-blind,
placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in
patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS)
after failure or intolerance to doxorubicin (or other anthracycline).
Five cohorts will be defined:
Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other
sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas
listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet
the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment
groups.