SUNRISE: This phase II/III study is assessing how safe and effective a new oral drug (unesbulin), compared to a placebo, is when given in combination with chemotherapy (dacarbazine) in people with inoperable, metastatic, relapsed or refractory leiomyosarcomaA Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or Placebo Comparator Arm. In the Experimental Arm, participants will receive unesbulin (300mg) tablets administered orally, twice weekly, in each 3-week treatment cycle, in combination with dacarbazine (1000mg/m^2) given intravenously once every 21 days. In the Placebo Comparator Arm, participants will receive placebo tablets administered orally twice weekly in each 3-week treatment cycle, in combination with dacarbazine (1000mg/m^2) administered intravenously once every 21 days.