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 leiomyosarcoma.
This trial is treating patients with leiomyosarcoma.
This is a systemic therapy trial.
You may be able to join this trial if:
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back.
- Your cancer has not spread to other parts of the body.
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Use the hyperlinks, where available to access additional clinical trial information.
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma
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.
Recruiting Hospitals Read More