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

NCT05269355 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 359

Last updated 2025-06-13

Study results available
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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.

Conditions

  • Leiomyosarcoma

Interventions

DRUG

Unesbulin

Unesbulin will be administered as per the dose and schedule specified in the arm description.

DRUG

Dacarbazine

Dacarbazine will be administered as per the dose and schedule specified in the arm description.

OTHER

Placebo

Placebo will be administered as per the schedule specified in the arm description.

Sponsors & Collaborators

Principal Investigators

  • Mark Rance, MD · PTC Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2024-06-17
Completion
2024-07-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05269355 on ClinicalTrials.gov