Trial · NCT00579501
Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma
NCT00579501, Phase 2, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2014-03-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma. Trials, record NCT00579501. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00579501
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma
- NCT number
- NCT00579501
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Liposarcoma,Myxoid
- Interventions
- Trabectedin, Dexamethasone
- First posted
- 2007-12-24
- Last updated
- 2014-05-07
- Results first posted
- 2014-03-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Pathological Complete Response (pCR) | Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. | Complete pathological response is complete disappearance of the tumor tissue up to the molecular level. |
| Secondary | Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST) | Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. | The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Pathological Complete Response (pCR) | Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. | Participants who received at least one cycle of trabectedin and have adequate pre and post trabectedin pathologic specimens available. Six participants were non evaluable for pCR assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST) | Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. | Participants who received at least one cycle of trabectedin and have at least one post baseline disease assessment. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) | Trabectedin | 13 | percentage of participants | ||
| Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST) | Trabectedin | 24.1 | percentage of participants |
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 | Trabectedin | 29 | |
| Overall Study | COMPLETED | Trabectedin | 0 | |
| Overall Study | NOT COMPLETED | Trabectedin | 29 |
Source ClinicalTrials.gov
Adverse events76
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 | Trabectedin | 2 | 29 | |
| other | Leukopenia | Blood and lymphatic system disorders | Trabectedin | 1 | 29 | |
| other | Neutropenia | Blood and lymphatic system disorders | Trabectedin | 14 | 29 | |
| other | Bradycardia | Cardiac disorders | Trabectedin | 1 | 29 | |
| other | Palpitations | Cardiac disorders | Trabectedin | 1 | 29 | |
| other | Tachycardia | Cardiac disorders | Trabectedin | 2 | 29 | |
| other | Ventricular extrasystoles | Cardiac disorders | Trabectedin | 1 | 29 | |
| other | Abdominal pain | Gastrointestinal disorders | Trabectedin | 4 | 29 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Trabectedin | 1 | 29 | |
| other | Constipation | Gastrointestinal disorders | Trabectedin | 7 | 29 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trabectedin | ||
| Total, other adverse events | Trabectedin | 28 | 29 |
| Total, serious adverse events | Trabectedin | 6 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21642514 | 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/NCT00579501
GET https://conductscience.org/api/trials/v1/NCT00579501/events?page=2