Trial · NCT05269355
A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)
NCT05269355, Phase 2, Phase 3, Terminated, PTC Therapeutics; results first posted 2025-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS). Trials, record NCT05269355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05269355
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)
- NCT number
- NCT05269355
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 359 participants, actual
- Lead sponsor
- PTC Therapeutics
- Conditions
- Leiomyosarcoma
- Interventions
- Unesbulin, Dacarbazine, Placebo
- First posted
- 2022-03-08
- Last updated
- 2025-06-13
- Other registries' IDs
- eudract:2022-000073-12
- Results first posted
- 2025-06-13
- Limitations and caveats
- The study was terminated early due to business decision.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Per Independent Central Review Using Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 | Up to approximately 2 years | 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. |
| Secondary | Overall Survival | Up to approximately 2 years | Overall survival was defined as the time in months from the randomization date to the date of death from any cause or date last known alive for those who did not die. |
| Secondary | Objective Response Rate (ORR) Per Independent Central Review Using RECIST V1.1 | Up to approximately 2 years | ORR was defined as percentage of participants who achieved a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Disease Control Rate (DCR) Per Independent Central Review Using RECIST V1.1 | Up to approximately 2 years | DCR was defined as percentage of participants who achieved a confirmed BOR of CR, PR, or at least 3 months of stable disease (SD). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Duration of Response Per Independent Central Review Using RECIST V1.1 | Up to approximately 2 years | Duration of response was defined as the time from the date of first confirmed response of CR or PR to the date of the first documented disease progression or death due to any cause, whichever occurred first. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression: 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 mm. The appearance of one or more new lesions was also considered progression. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug up to approximately 2 years | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A TEAE was defined as an AE that had an onset date on or after the first dose of study drug until 30 days after last dose or occurred prior to first dose of study drug and worsened in severity after first dose of study drug. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) Per Independent Central Review Using Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 | Up to approximately 2 years | The modified intent-to-treat (mITT) set included randomized participants with 1 to 3 prior lines of therapy. | months | MEDIAN |
| SECONDARY | Overall Survival | Up to approximately 2 years | The mITT set included randomized participants with 1 to 3 prior lines of therapy. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per Independent Central Review Using RECIST V1.1 | Up to approximately 2 years | The mITT set included randomized participants with 1 to 3 prior lines of therapy. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) Per Independent Central Review Using RECIST V1.1 | Up to approximately 2 years | The mITT set included randomized participants with 1 to 3 prior lines of therapy. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response Per Independent Central Review Using RECIST V1.1 | Up to approximately 2 years | The mITT set included randomized participants with 1 to 3 prior lines of therapy. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug up to approximately 2 years | The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) Per Independent Central Review Using Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 | Unesbulin and Dacarbazine | 3.6 | 95% Confidence Interval 2.8 to 5.5 | months | |
| Progression Free Survival (PFS) Per Independent Central Review Using Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 | Placebo and Dacarbazine | 2.6 | 95% Confidence Interval 1.5 to 3.0 | months | |
| Overall Survival | Unesbulin and Dacarbazine | NA | 95% Confidence Interval 10.4 to NA | months | |
| Overall Survival | Placebo and Dacarbazine | NA | 95% Confidence Interval 11.0 to NA | months | |
| Objective Response Rate (ORR) Per Independent Central Review Using RECIST V1.1 | Unesbulin and Dacarbazine | 8.1 | 95% Confidence Interval 4.7 to 12.8 | percentage of participants | |
| Objective Response Rate (ORR) Per Independent Central Review Using RECIST V1.1 | Placebo and Dacarbazine | 2.1 | 95% Confidence Interval 0.3 to 7.3 | percentage of participants | |
| Disease Control Rate (DCR) Per Independent Central Review Using RECIST V1.1 | Unesbulin and Dacarbazine | 36.4 | 95% Confidence Interval 29.7 to 43.5 | percentage of participants | |
| Disease Control Rate (DCR) Per Independent Central Review Using RECIST V1.1 | Placebo and Dacarbazine | 27.1 | 95% Confidence Interval 18.5 to 37.1 | percentage of participants | |
| Duration of Response Per Independent Central Review Using RECIST V1.1 | Unesbulin and Dacarbazine | 6.87 | 95% Confidence Interval NA to NA | months | |
| Duration of Response Per Independent Central Review Using RECIST V1.1 | Placebo and Dacarbazine | NA | 95% Confidence Interval NA to NA | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Unesbulin and Dacarbazine | 239 | |
| Overall Study | STARTED | Placebo and Dacarbazine | 120 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Unesbulin and Dacarbazine | 238 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo and Dacarbazine | 120 | |
| Overall Study | COMPLETED | Unesbulin and Dacarbazine | 0 | |
| Overall Study | COMPLETED | Placebo and Dacarbazine | 0 | |
| Overall Study | NOT COMPLETED | Unesbulin and Dacarbazine | 239 | |
| Overall Study | NOT COMPLETED | Placebo and Dacarbazine | 120 |
Source ClinicalTrials.gov
Adverse events286
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Unesbulin and Dacarbazine | 103 | 238 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo and Dacarbazine | 35 | 120 | |
| other | Leukopenia | Blood and lymphatic system disorders | Unesbulin and Dacarbazine | 15 | 238 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo and Dacarbazine | 7 | 120 | |
| other | Neutropenia | Blood and lymphatic system disorders | Unesbulin and Dacarbazine | 88 | 238 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo and Dacarbazine | 23 | 120 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Unesbulin and Dacarbazine | 75 | 238 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo and Dacarbazine | 27 | 120 | |
| other | Abdominal pain | Gastrointestinal disorders | Unesbulin and Dacarbazine | 42 | 238 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo and Dacarbazine | 11 | 120 |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Unesbulin and Dacarbazine | 49 | 238 |
| Total, all-cause mortality | Placebo and Dacarbazine | 27 | 120 |
| Total, other adverse events | Unesbulin and Dacarbazine | 234 | 238 |
| Total, other adverse events | Placebo and Dacarbazine | 112 | 120 |
| Total, serious adverse events | Unesbulin and Dacarbazine | 81 | 238 |
| Total, serious adverse events | Placebo and Dacarbazine | 43 | 120 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Unesbulin and Dacarbazine vs Placebo and Dacarbazine: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Unesbulin and Dacarbazine vs Placebo and Dacarbazine: deaths from any cause | Trial comparisons |
| Unesbulin and Dacarbazine vs Placebo and Dacarbazine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05269355
GET https://conductscience.org/api/trials/v1/NCT05269355/events?page=2