A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)

Summary

This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy.

Timeline

Start

2022-05-23

Primary completion

2024-06-17

Completion

2024-07-17

Outcome

Met primary endpoint

Stopped (Business): “Business decision”

registry analysis (other test); Unesbulin and Dacarbazine vs Placebo and Dacarbazine; p = 0.0017; Hazard Ratio (HR) 0.61 (95% CI 0.45 to 0.83); Regression, Cox NCT05269355 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Unesbulin	Small molecule	300 mg	Oral
Background	Dacarbazine	Small molecule	1000 mg/m2	Intravenous

Indications