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NCT05269355 · ClinicalTrials.gov registry record · Phase 2
A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)
A Phase 2 study, sponsored by PTC Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 359
- Enrollment target
NCT05269355: Clinical Trial Phase 2 study, sponsored by PTC Therapeutics.
NCT05269355 is a Phase 2 study that was terminated before completion, run by PTC Therapeutics. The registered enrollment target is 359 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (170% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05269355, a Phase 2 study, was terminated before completion, sponsored by PTC Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 359 participants
- Enrollment target
Study 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.
Primary Outcome
PFS was defined as the time from randomization to the documented disease progression or death due to any cause, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression.
Interventions
- OTHER Placebo
- DRUG Dacarbazine
- DRUG Unesbulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 359 participants |
| Start Date | 2022-05-23 |
| Est. Completion | 2024-07-17 |
| Phase | Phase 2 |
Why NCT05269355 stopped before completion
NCT05269355 is an interventional study that assigns participants to a tested intervention. The registered 359 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (170% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05269355 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05269355 about?
NCT05269355 is a clinical study titled "A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)". 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.
What is the current status of trial NCT05269355?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 359 participants. The study started on 2022-05-23. Estimated completion is 2024-07-17.
What interventions are being tested in trial NCT05269355?
The interventions under investigation include: Placebo (OTHER), Dacarbazine (DRUG), Unesbulin (DRUG).
Who is sponsoring clinical trial NCT05269355?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05269355's enrollment target sits among peer trials
359 127th of 2000 higher than 1,874 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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