Trial · NCT04979442
Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma
NCT04979442, Phase 3, Terminated, Rain Oncology Inc; results first posted 2025-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma. Trials, record NCT04979442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04979442
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma
- NCT number
- NCT04979442
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 175 participants, actual
- Lead sponsor
- Rain Oncology Inc
- Conditions
- Dedifferentiated Liposarcoma
- Interventions
- RAIN-32, Trabectedin
- First posted
- 2021-07-28
- Last updated
- 2025-01-14
- Results first posted
- 2025-01-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compare Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) Between the Milademetan Treatment Arm and Trabectedin Control Arm | from the randomization date to date of documented progression or death, up to 13 months | PFS is defined as the time from randomization to the earliest date of the first objective documentation of radiographic disease progression, or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival (OS) | From randomization date to death. The result is based on primary analysis data cut. | OS as measured from the date of randomization to date of death by any cause |
| Secondary | Disease Control Rate (DCR) | From the randomization date to first CR, PR or SD >= 16 weeks or the primary study completion date; up to 26.6 months. | DCR defined as the percentage of patients who have achieved CR, PR, or SD for \>= 16 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Objective Response Rate (ORR) | From randomization date to the first confirmed complete or partial response, or study completion date; up to 26.6 months. | ORR defined as the percentage of patients who have achieved a confirmed CR, PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. |
| Secondary | PFS by Investigator Assessments | disease progression or death | PFS defined as the time from randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, based on Investigator assessments |
| Secondary | Number of Participants With Treatment-emergent Adverse Events Until Approximately 30 Days After the Last Study Drug | From first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months. | All AEs were collected from the initiation of study treatment until 30 days after the last administration study drug or until initiation of another anticancer therapy, whichever came first; up to 26.6 months. |
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 | Compare Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) Between the Milademetan Treatment Arm and Trabectedin Control Arm | from the randomization date to date of documented progression or death, up to 13 months | Analysis population included all the randomized participants up to up to final analysis cut-off date (01 March 2023). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization date to death. The result is based on primary analysis data cut. | Analysis population included all the randomized participants up to up to final analysis cut-off date (01 March 2023). | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | From the randomization date to first CR, PR or SD >= 16 weeks or the primary study completion date; up to 26.6 months. | percentage of participants | NUMBER | |
| SECONDARY | Objective Response Rate (ORR) | From randomization date to the first confirmed complete or partial response, or study completion date; up to 26.6 months. | This analysis is conducted in all participants within the Intent to treat (IIT) population | percentage of participants | NUMBER |
| SECONDARY | PFS by Investigator Assessments | disease progression or death | PFS defined as the time from randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, based on Investigator assessments | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events Until Approximately 30 Days After the Last Study Drug | From first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months. | All AEs were collected from the initiation of study treatment until 30 days after the last administration study drug or until initiation of another anticancer therapy, whichever came first. | 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 |
|---|---|---|---|---|---|
| Compare Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) Between the Milademetan Treatment Arm and Trabectedin Control Arm | Milademetan | 3.6 | 95% Confidence Interval 2.1 to 4.1 | months | |
| Compare Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) Between the Milademetan Treatment Arm and Trabectedin Control Arm | Trabectedin | 2.2 | 95% Confidence Interval 1.9 to 4.2 | months | |
| Overall Survival (OS) | Milademetan | 9.5 | 95% Confidence Interval 6.5 to 12.8 | months | |
| Overall Survival (OS) | Trabectedin | 10.2 | 95% Confidence Interval 8.6 to NA | months | |
| Disease Control Rate (DCR) | Milademetan | 33.7 | 95% Confidence Interval 23.9 to 44.7 | percentage of participants | |
| Disease Control Rate (DCR) | Trabectedin | 27.0 | 95% Confidence Interval 18.1 to 37.4 | percentage of participants | |
| Objective Response Rate (ORR) | Milademetan | 4.7 | 95% Confidence Interval 1.3 to 11.5 | percentage of participants | |
| Objective Response Rate (ORR) | Trabectedin | 3.4 | 95% Confidence Interval 0.7 to 9.5 | percentage of participants | |
| PFS by Investigator Assessments | Milademetan | 3.7 | 95% Confidence Interval 2.1 to 5.4 | months | |
| PFS by Investigator Assessments | Trabectedin | 2.1 | 95% Confidence Interval 1.9 to 3.9 | 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 | Milademetan | 86 | |
| Overall Study | STARTED | Trabectedin | 89 | |
| Overall Study | Received Treatment | Milademetan | 86 | |
| Overall Study | Received Treatment | Trabectedin | 79 | |
| Overall Study | COMPLETED | Milademetan | 34 | |
| Overall Study | COMPLETED | Trabectedin | 42 | |
| Overall Study | NOT COMPLETED | Milademetan | 52 | |
| Overall Study | NOT COMPLETED | Trabectedin | 47 |
Source ClinicalTrials.gov
Adverse events130
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 | Nausea | Gastrointestinal disorders | Milademetan | 61 | 86 | |
| other | Nausea | Gastrointestinal disorders | Trabectedin | 46 | 79 | |
| other | Anemia | Blood and lymphatic system disorders | Milademetan | 38 | 86 | |
| other | Anemia | Blood and lymphatic system disorders | Trabectedin | 29 | 79 | |
| other | Vomiting | Gastrointestinal disorders | Milademetan | 38 | 86 | |
| other | Vomiting | Gastrointestinal disorders | Trabectedin | 15 | 79 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Milademetan | 31 | 86 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Trabectedin | 11 | 79 | |
| other | Fatigue | General disorders | Milademetan | 30 | 86 | |
| other | Fatigue | General disorders | Trabectedin | 26 | 79 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Milademetan | 43 | 86 |
| Total, all-cause mortality | Trabectedin | 30 | 89 |
| Total, other adverse events | Milademetan | 86 | 86 |
| Total, other adverse events | Trabectedin | 78 | 79 |
| Total, serious adverse events | Milademetan | 31 | 86 |
| Total, serious adverse events | Trabectedin | 38 | 79 |
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 |
|---|---|
| Milademetan vs Trabectedin: Number of Participants With Treatment-emergent Adverse Events Until Approximately 30 Days After the Last Study Drug | Trial comparisons |
| Milademetan vs Trabectedin: deaths from any cause | Trial comparisons |
| Milademetan vs Trabectedin: 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/NCT04979442
GET https://conductscience.org/api/trials/v1/NCT04979442/events?page=2