Trial · NCT00060944
A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
NCT00060944, Phase 2, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2014-09-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer. Trials, record NCT00060944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00060944
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
- NCT number
- NCT00060944
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 271 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Liposarcoma, Leiomyosarcoma
- Interventions
- Yondelis, Yondelis, Dexamethasone, Dexamethasone
- First posted
- 2003-05-19
- Last updated
- 2014-09-08
- Results first posted
- 2014-09-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Progression- Independent Review | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease. |
| Secondary | Percentage of Participants Objective Response - Independent Review | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. |
| Secondary | Duration of Response - Independent Review | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response. |
| Secondary | Progression-Free Survival - Independent Review | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. |
| Secondary | Overall Survival | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Progression- Independent Review | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. | months | MEDIAN |
| SECONDARY | Percentage of Participants Objective Response - Independent Review | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response - Independent Review | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. Participants with confirmed response only were analyzed. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival - Independent Review | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. | months | MEDIAN |
| SECONDARY | Overall Survival | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Progression- Independent Review | Trabectedin 1.5 mg/m2 | 3.7 | 95% Confidence Interval 2.1 to 5.4 | months | |
| Time to Progression- Independent Review | Trabectedin 0.58 mg/m2 | 2.3 | 95% Confidence Interval 2.0 to 3.5 | months | |
| Percentage of Participants Objective Response - Independent Review | Trabectedin 1.5 mg/m2 | 5.1 | 95% Confidence Interval 2.1 to 10.3 | Percentage of participants | |
| Percentage of Participants Objective Response - Independent Review | Trabectedin 0.58 mg/m2 | 1.5 | 95% Confidence Interval 0.2 to 5.3 | Percentage of participants | |
| Duration of Response - Independent Review | Trabectedin 1.5 mg/m2 | 7.5 | 95% Confidence Interval 6.1 to 7.8 | Months | |
| Duration of Response - Independent Review | Trabectedin 0.58 mg/m2 | NA | 95% Confidence Interval 3.4 to NA | Months | |
| Progression-Free Survival - Independent Review | Trabectedin 1.5 mg/m2 | 3.3 | 95% Confidence Interval 2.1 to 4.6 | months | |
| Progression-Free Survival - Independent Review | Trabectedin 0.58 mg/m2 | 2.3 | 95% Confidence Interval 2.0 to 3.4 | months | |
| Overall Survival | Trabectedin 1.5 mg/m2 | 13.9 | 95% Confidence Interval 12.5 to 18.6 | months | |
| Overall Survival | Trabectedin 0.58 mg/m2 | 11.8 | 95% Confidence Interval 9.9 to 14.9 | months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trabectedin 1.5 mg/m2 | 136 | |
| Overall Study | STARTED | Trabectedin 0.58 mg/m2 | 134 | |
| Overall Study | Treated | Trabectedin 1.5 mg/m2 | 130 | |
| Overall Study | Treated | Trabectedin 0.58 mg/m2 | 130 | |
| Overall Study | COMPLETED | Trabectedin 1.5 mg/m2 | 0 | |
| Overall Study | COMPLETED | Trabectedin 0.58 mg/m2 | 0 | |
| Overall Study | NOT COMPLETED | Trabectedin 1.5 mg/m2 | 136 | |
| Overall Study | NOT COMPLETED | Trabectedin 0.58 mg/m2 | 134 |
Source ClinicalTrials.gov
Adverse events332
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 1.5 mg/m2 | 42 | 130 | |
| other | Anaemia | Blood and lymphatic system disorders | Trabectedin 0.58 mg/m2 | 40 | 130 | |
| other | Leukopenia | Blood and lymphatic system disorders | Trabectedin 1.5 mg/m2 | 16 | 130 | |
| other | Leukopenia | Blood and lymphatic system disorders | Trabectedin 0.58 mg/m2 | 9 | 130 | |
| other | Neutropenia | Blood and lymphatic system disorders | Trabectedin 1.5 mg/m2 | 64 | 130 | |
| other | Neutropenia | Blood and lymphatic system disorders | Trabectedin 0.58 mg/m2 | 36 | 130 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Trabectedin 1.5 mg/m2 | 25 | 130 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Trabectedin 0.58 mg/m2 | 10 | 130 | |
| other | Abdominal Distension | Gastrointestinal disorders | Trabectedin 1.5 mg/m2 | 8 | 130 | |
| other | Abdominal Distension | Gastrointestinal disorders | Trabectedin 0.58 mg/m2 | 10 | 130 |
1 to 10 of 332Source ClinicalTrials.gov
See all 332 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trabectedin 1.5 mg/m2 | ||
| Total, all-cause mortality | Trabectedin 0.58 mg/m2 | ||
| Total, other adverse events | Trabectedin 1.5 mg/m2 | 129 | 130 |
| Total, other adverse events | Trabectedin 0.58 mg/m2 | 128 | 130 |
| Total, serious adverse events | Trabectedin 1.5 mg/m2 | 48 | 130 |
| Total, serious adverse events | Trabectedin 0.58 mg/m2 | 41 | 130 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Trabectedin 1.5 mg/m2 vs Trabectedin 0.58 mg/m2: serious adverse events |
Source 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/NCT00060944
GET https://conductscience.org/api/trials/v1/NCT00060944/events?page=2