Trial · NCT05116683
ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma
NCT05116683, Phase 2, Terminated, Benjamin Izar; results first posted 2023-12-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma. Trials, record NCT05116683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05116683
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma
- NCT number
- NCT05116683
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Benjamin Izar
- Conditions
- Leiomyosarcoma, Liposarcoma
- Interventions
- ATX-101
- First posted
- 2021-11-11
- Last updated
- 2023-12-06
- Results first posted
- 2023-12-06
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 Rate (PFR) | 12 weeks | The study will evaluate the preliminary efficacy of ATX-101 in advanced L-sarcomas (LMS, LPS) by measuring the PFR (progression free rate) at 12 weeks (PFR12). Progression evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest 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 is also considered progression). |
| Secondary | Number of Adverse Events | Up to approximately 7 months | Counted per adverse event basis by grade as evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The higher the grade, the more severe the event. |
| Secondary | Objective Response Rate (ORR) | Up to approximately 7 months | The percentage of patients whose cancer shrinks or disappears after treatment. This will be measured by the percentage of patients having a complete or partial response per RECIST Version 1.1. ORR = Complete Response (CR) + Partial Response (PR); CR defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm and PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Duration of the Response | Up to approximately 7 months | Duration of response is measured from the time the measurement criteria for an objective response is recorded until the first date that recurrent or progressive disease is objectively documented. |
| Secondary | Median Progression Free Survival (PFS) | Up to approximately 5 months | Median time from start treatment until the time of progression or death. |
| Secondary | Median Overall Survival (OS) | Up to approximately 7 months | Median time from start of treatment until the time of death from any cause. |
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 Rate (PFR) | 12 weeks | Three of four participants analyzed due to n=1 participant who expired prior to week 12 (stable disease at time of death). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Adverse Events | Up to approximately 7 months | Adverse Events | NUMBER | |
| SECONDARY | Objective Response Rate (ORR) | Up to approximately 7 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of the Response | Up to approximately 7 months | Zero analyzed as zero participants demonstrated objective response. | ||
| SECONDARY | Median Progression Free Survival (PFS) | Up to approximately 5 months | months | MEDIAN | |
| SECONDARY | Median Overall Survival (OS) | Up to approximately 7 months | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Rate (PFR) | ATX-101 | 1 | Participants | ||
| Number of Adverse Events | ATX-101 | Grade 1 | 13 | Adverse Events | |
| Number of Adverse Events | ATX-101 | Grade 2 | 16 | Adverse Events | |
| Number of Adverse Events | ATX-101 | Grade 3 | 4 | Adverse Events | |
| Number of Adverse Events | ATX-101 | Grade 4 | 0 | Adverse Events | |
| Number of Adverse Events | ATX-101 | Grade 5 | 0 | Adverse Events | |
| Objective Response Rate (ORR) | ATX-101 | 0 | Participants | ||
| Median Progression Free Survival (PFS) | ATX-101 | 2.46 | Full Range 1.28 to 5.19 | months | |
| Median Overall Survival (OS) | ATX-101 | 4.40 | Full Range 2.53 to 6.64 | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ATX-101 | 4 | |
| Overall Study | COMPLETED | ATX-101 | 0 | |
| Overall Study | NOT COMPLETED | ATX-101 | 4 |
Source ClinicalTrials.gov
Adverse events22
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 | Anemia | Blood and lymphatic system disorders | ATX-101 | 1 | 4 | |
| other | Anorexia | Metabolism and nutrition disorders | ATX-101 | 2 | 4 | |
| other | Blood bilirubin increased | Investigations | ATX-101 | 1 | 4 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | ATX-101 | 1 | 4 | |
| other | Dry mouth | Gastrointestinal disorders | ATX-101 | 1 | 4 | |
| other | Dysgeusia | Nervous system disorders | ATX-101 | 1 | 4 | |
| other | Fatigue | General disorders | ATX-101 | 1 | 4 | |
| other | Generalized edema | General disorders | ATX-101 | 1 | 4 | |
| other | Infusion related reaction | General disorders | ATX-101 | 3 | 4 | |
| other | Nausea | Gastrointestinal disorders | ATX-101 | 1 | 4 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATX-101 | 4 | 4 |
| Total, other adverse events | ATX-101 | 4 | 4 |
| Total, serious adverse events | ATX-101 | 1 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39034053 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05116683
GET https://conductscience.org/api/trials/v1/NCT05116683/events?page=2