PTC596-LMS (Leiomyosarcoma)

What is the Purpose of this Study?

We are doing this study to find out if a study drug called unesbulin is a safe and effective option that can help people with a type of soft tissue sarcoma called leiomyosarcoma.

What is the Condition Being Studied?

Advanced Leiomyosarcoma

Who Can Participate in the Study?

Adults ages 18+ who are diagnosed with locally advanced leiomyosarcoma.

For more information on who can participate in this study please contact the study team at debra.shoemaker@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment to 1 of 2 groups:
- One group will the study drug in combination with a standard drug called dacarbazine
- The other group will get a placebo (inactive substance that has no drug in it) in combination with dacarbazine

No matter to which group you are assigned, during the study you will:
- Have physical exams, electrocardiograms (ECG), and blood draws
- Have CT or MRI scans

You will visit our clinic for follow-up visits after you stop taking the study drugs, and we will keep in touch with you to see how you are feeling.

Study Details

Full Title
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma
Principal Investigator
Associate Professor in Medicine
Protocol Number
IRB: PRO00110891
NCT: NCT05269355
Phase
Phase II/III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL