Trials / Terminated
TerminatedNCT05269355
A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 359 (actual)
- Sponsor
- PTC Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-05-23
- Primary completion
- 2024-06-17
- Completion
- 2024-07-17
- First posted
- 2022-03-08
- Last updated
- 2025-06-13
- Results posted
- 2025-06-13
Locations
54 sites across 12 countries: United States, Australia, Brazil, Canada, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05269355. Inclusion in this directory is not an endorsement.