Trial · NCT01876043
Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial
NCT01876043, Phase 2, Terminated, Institut Bergonié; results first posted 2019-11-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial. Trials, record NCT01876043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01876043
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial
- NCT number
- NCT01876043
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Institut Bergonié
- Conditions
- Adult Patients With Unresectable Locally Advanced or Metastatic, Relapsed/Refractory Dedifferentiated Liposarcoma
- Interventions
- plitidepsin
- First posted
- 2013-06-12
- Last updated
- 2021-01-25
- Results first posted
- 2019-11-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Remaining Alive and Progression Free at 3 Months (i.e. Week 12 ± 1) as Per RECIST1.1 (PFS3). | 3 months | Progression is defined using New Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. |
| Secondary | Percentage of Patients With Objective Response at Six Months (as Per RECIST v1.1) | 6 months | Objective response assessed as per New Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; Overall Response (OR) = CR + PR. |
| Secondary | Percentage of Patients Remaining Alive and Progression Free at 6 Months as Per RECIST1.1. | 6 months | Progression is defined using New Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. |
| Secondary | Progression-free Survival | from start of study treatment to the end of the study (up to 10 months) | Progression-free survival is defined as the delay between the start date of treatment and the date of progression or death (from any cause), whichever occurs first. Patients alive and progression free were censored at the date of last follow-up, death, or last patient contact. Progression is assessed as per RECIST v1.1. |
| Secondary | 1-year Overall Survival (OS) Rate | 1 year | |
| Secondary | Treatment Safety (AEs, SAEs and Laboratory Abnormalities) Graded According to the NCI-CTCAE Version 4.0. | through study completion, an average of 1 year | Toxicity were graded according to the NCI-CTCAE version 4.0. |
| Secondary | Number of Participants With a Biomarker Amplification | through study completion, an average of 1 year | Genomic status of biomarkers obtained by using array-comparative genomic hybridization. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Remaining Alive and Progression Free at 3 Months (i.e. Week 12 ± 1) as Per RECIST1.1 (PFS3). | 3 months | 22 patients who completed study i.e who completed one cycle or two incomplete cycles of treatment were analyzed for final efficacy analysis. Out of these 22 patients who completed study, the first 17 patients (first stage of the 2-stage Simon's optimal design ) were analyzed for interim efficacy analysis based on primary endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Objective Response at Six Months (as Per RECIST v1.1) | 6 months | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients Remaining Alive and Progression Free at 6 Months as Per RECIST1.1. | 6 months | percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival | from start of study treatment to the end of the study (up to 10 months) | months | MEDIAN | |
| SECONDARY | 1-year Overall Survival (OS) Rate | 1 year | percentage of overall survival | NUMBER | |
| SECONDARY | Treatment Safety (AEs, SAEs and Laboratory Abnormalities) Graded According to the NCI-CTCAE Version 4.0. | through study completion, an average of 1 year | adverse events | NUMBER | |
| SECONDARY | Number of Participants With a Biomarker Amplification | through study completion, an average of 1 year | 19 patients (out of the 22 patients) for whom translational research have been performed. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Remaining Alive and Progression Free at 3 Months (i.e. Week 12 ± 1) as Per RECIST1.1 (PFS3). | Plitidepsin | Final efficacy analysis | 9.1 | 95% Confidence Interval 1.1 to 29.2 | percentage of participants |
| Percentage of Patients Remaining Alive and Progression Free at 3 Months (i.e. Week 12 ± 1) as Per RECIST1.1 (PFS3). | Plitidepsin | Interim analysis population | 5.9 | 95% Confidence Interval 0.15 to 28.7 | percentage of participants |
| Percentage of Patients With Objective Response at Six Months (as Per RECIST v1.1) | Plitidepsin | 0 | 95% Confidence Interval 0 to 0 | percentage of participants | |
| Percentage of Patients Remaining Alive and Progression Free at 6 Months as Per RECIST1.1. | Plitidepsin | 0 | 95% Confidence Interval 0 to 0 | percentage of participants | |
| Progression-free Survival | Plitidepsin | 1.6 | 95% Confidence Interval 1.4 to 2.6 | months | |
| 1-year Overall Survival (OS) Rate | Plitidepsin | 40.9 | 95% Confidence Interval 20.9 to 60.1 | percentage of overall survival | |
| Treatment Safety (AEs, SAEs and Laboratory Abnormalities) Graded According to the NCI-CTCAE Version 4.0. | Plitidepsin | 232 | adverse events | ||
| Number of Participants With a Biomarker Amplification | Plitidepsin | 2 | participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Plitidepsin | 24 | |
| Overall Study | Interim Analysis Population | Plitidepsin | 17 | |
| Overall Study | COMPLETED | Plitidepsin | 22 | |
| Overall Study | NOT COMPLETED | Plitidepsin | 2 |
Source ClinicalTrials.gov
Adverse events51
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 | Plitidepsin | 7 | 24 | |
| other | Abdominal distension | Gastrointestinal disorders | Plitidepsin | 3 | 24 | |
| other | Abdominal pain | Gastrointestinal disorders | Plitidepsin | 3 | 24 | |
| other | CONSTIPATION | Gastrointestinal disorders | Plitidepsin | 4 | 24 | |
| other | DIARRHEA | Gastrointestinal disorders | Plitidepsin | 10 | 24 | |
| other | NAUSEA | Gastrointestinal disorders | Plitidepsin | 19 | 24 | |
| other | VOMITING | Gastrointestinal disorders | Plitidepsin | 7 | 24 | |
| other | EDEMA LIMBS | General disorders | Plitidepsin | 6 | 24 | |
| other | FATIGUE | General disorders | Plitidepsin | 22 | 24 | |
| other | FEVER | General disorders | Plitidepsin | 5 | 24 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Plitidepsin | ||
| Total, other adverse events | Plitidepsin | 24 | 24 |
| Total, serious adverse events | Plitidepsin | 12 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26041763 | RESULT |
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/NCT01876043
GET https://conductscience.org/api/trials/v1/NCT01876043/events?page=2